Larry C. Guess maintains a general health industry practice, focusing on transactional and regulatory matters. He focuses on representing private equity firms and platform companies, hospitals, health systems and life science companies. Larry has experience with a variety of transactions, including mergers, acquisitions, affiliation and product licensing arrangements. He also provides guidance on regulatory issues such as licensure, corporate practice of medicine, dentistry, physical and speech therapy, and compliance with Stark Law and the Anti-Kickback Statute.

Previously, Larry spent more than a decade in the healthcare industry, marketing pharmaceuticals and medical devices for several Fortune 500 companies. During this time, he brought five multimillion-dollar products to market in major hospital systems across the United States. While in law school, he served as chair of the Accelerated Juris Doctor Board Association. While earning his Master of Business Administration, he served as chair of the Healthcare and Biotech Club, and the Black Management Association.

Leads M&A and strategic partnerships for outpatient service providers and private equity funds

Structures outpatient service platforms with expertise in physician alignment and compensation

Advises investors on sector-specific due diligence across specialized healthcare services

Counsels on federal and state regulatory compliance for outpatient services transactions

Develops state of the art care-delivery models for outpatient service providers

Advises on various federal and state regulatory matters and serves as a liaison with Texas regulatory agencies

Joseph (Joe) M. Parise advises healthcare clients on a wide range of transactional and regulatory matters across the United States. He serves as counsel to private equity firms and their portfolio companies, physician practices, practice management companies, behavioral health providers, hospitals and health systems.

Joe has experience executing a variety of transactions within the healthcare industry, including mergers, acquisitions, joint ventures, affiliations and divestitures. He also works with clients to navigate the complex strategic and regulatory issues associated with those transactions.

He also provides guidance to clients on sector-specific regulatory issues including with respect to the practice of medicine, dentistry and physical therapy, state licensure and certificate of need, behavioral health and behavior analysis, and pharmacy and clinical laboratory matters.

Advises private equity funds and strategic investors on transactional and regulatory matters in the healthcare services industry  

Represents physician practice management companies and other healthcare services platforms on transactional and regulatory matters.  

Counsels hospital and post-acute provider clients on strategic joint ventures, affiliations, and regulatory matters  

Leads healthcare and life sciences M&A transactions across a broad array of healthcare sectors

Represents healthcare private equity funds with fully integrated transactional, finance, and regulatory counsel

Structures large physician practice roll-ups and MSO platforms across specialties, including emerging non-healthcare professional services models

Advises private equity sponsors and founders on mergers, acquisitions, joint ventures, and strategic contractual arrangements

Serves as external general counsel to private-equity-backed and founder-owned companies, counseling them on regulatory, employment, equity incentive, commercial contract, and corporate governance matters

Offers deep insights into highly regulated transactions, including those structured in the PC/MSO model, such as healthcare practices and professional services firms

Nicholas F. Alarif focuses his practice on healthcare regulatory and fraud and abuse matters, including the physician self-referral law (Stark Law), False Claims Act (FCA), the Federal Anti-Kickback Statute and other healthcare compliance matters. He also advises clients on the complex legal and factual issues surrounding Medicare Parts A–D reimbursement and other Centers for Medicare & Medicaid Services (CMS) payment policies. With his combination of in-house, federal government and Big Law experience, Nick provides well-rounded and actionable counsel to healthcare clients, with business objectives and compliance at the forefront.

Prior to rejoining McDermott, Nicholas served as systems director and senior corporate counsel for one of the country’s largest non-profit health systems. He also worked within CMS where he focused on Stark Law matters, including regulatory policy, the Stark Law Self-Referral Disclosure Protocol, advisory opinions and providing technical assistance to the US Department of Justice on FCA investigations and litigation. Before CMS, Nicholas worked at the US Department of Health & Human Services Office of Medicare Hearings and Appeals. Nicholas also currently serves as an adjunct professor of Healthcare Fraud & Abuse at the American University Washington College of Law.

Jiayan Chen is an industry leader on matters relating to health data, technology and research. She represents clients on regulatory and compliance matters, commercial transactions, and investments and acquisitions that require deep knowledge of privacy, data strategies, artificial intelligence (AI) and other healthcare technologies, or research compliance. Clients turn to Jiayan for her practical, industry-informed guidance as they seek to develop, improve, deploy, or acquire solutions or businesses that harness the power of data or technology. Jiayan has extensive experience advising on investments and acquisitions in the life sciences sector, particularly with respect to businesses that conduct clinical research or offer solutions designed to accelerate research or research recruitment. Her practice includes working with patient safety organizations (PSOs) on listing applications, compliance, and strategies for appropriately creating and sharing patient safety work product.

Jiayan’s subject matter and industry insights come from advising a broad range of clients, including AI and other healthcare technology companies; data companies; hospitals and health systems; academic medical centers; genetics companies; digital health companies; PSOs; drug, device, and biotech companies; private equity funds; and platform companies.

Jiayan regularly counsels clients on data privacy requirements under US federal and state privacy law, including the Health Insurance Portability and Accountability Act (HIPAA) and various state genetic, health information, and consumer privacy laws. She works with clients on mapping and implementing data use and sharing strategies with appropriate data governance and programmatic safeguards. Well before the proliferation of generative AI, Jiayan was working with AI developers and deployers on compliance with privacy and research laws, efforts to leverage data to train and validate AI tools, and transactions involving the licensing of AI tools and AI-enabled platforms. These days, Jiayan also guides clients in developing AI governance and advises on proposed regulatory and legislative changes impacting AI.

Jiayan represents clients on a wide array of matters related to biomedical research, including negotiating the full range of agreements impacting research, building research compliance infrastructure, preparing protocols and informed consent and authorizations, and conducting transactions involving research site networks, providers of research solutions and other stakeholders in the biomedical research space. Jiayan’s regulatory practice includes counseling clients on state and federal “sunshine” and gift ban laws. She analyzes proposed arrangements and corporate organizational structures to identify and inform reporting obligations, and helps clients develop compliance mechanisms for managing their reporting obligations.

Defends mergers and competitor collaborations in the healthcare industry through federal and state antitrust enforcement agency review

Advises on ongoing conduct and antitrust compliance matters, including provider contracting networks, joint purchasing arrangements, information exchanges, and other forms of competitor collaborations

Jamie Gelfman is board certified in health law by the Florida Bar Board of Legal Specialization and Education and is certified in healthcare compliance (CHC) by the Health Care Compliance Association. Jamie works with healthcare clients on the full scope of legal issues that shape their business strategies. She is deeply experienced in regulatory, compliance, reimbursement, enrollment and licensure matters, with particular experience in the administration of Medicare and Medicaid programs, fraud and abuse, and scope of practice issues. With more than a decade of healthcare legal experience based in Florida, Jamie is a valuable partner for healthcare companies doing business in or working to expand operations in the state.

Jamie applies her regulatory insights to help clients proactively navigate complex state and federal reimbursement laws. She also handles regulatory due diligence for healthcare transactions, helping assess private equity deals and other healthcare transactions to minimize risk for her clients and maximize deal efficiencies.

In addition, Jamie defends clients facing disciplinary actions initiated by state agencies and professional licensure boards – another area where her experience in the Florida healthcare space provides her with unique insights. She also defends clients facing fraud and abuse investigations, qui tam actions and healthcare-related litigation and insolvency matters.

Advises on complex healthcare transactions, including mergers, acquisitions, joint ventures, and divestitures of healthcare companies  

Focuses on ASC transactions and PPM platform growth and development on a national scale  

Represents private equity funds, platform companies, strategic investors, publicly traded companies, physicians, and family offices across a range of healthcare transactions  

Structures transactions to comply with state and federal fraud and abuse laws, licensure requirements, and corporate practice of medicine prohibitions

With a focus on complex transactions and regulatory compliance, Patrick Healy represents a wide range of healthcare industry participants, including non-profit and for-profit health systems, academic medical centers, physician organizations, post-acute providers and health plans. He works alongside his clients to execute their most critical transactions and strategic initiatives, leveraging corporate and healthcare regulatory expertise to drive an efficient and client-oriented approach to achieving his client’s business goals. Patrick has helped his clients navigate and successfully close more than 100 healthcare transactions with a focus on mergers, acquisitions, strategic affiliations, classic and contractual joint ventures and joint operating arrangements.

Patrick also routinely advises clients on a variety of transactional and regulatory matters related to value-based payment programs and delivery systems, leveraging his health economics and healthcare policy backgrounds in doing so. He assists accountable care organizations (Medicare, Medicaid, commercial) and other clinically integrated networks with formation, regulatory compliance, physician and management company joint ventures and participating provider relationships. Patrick advises hospitals and physician groups on their participation in Medicare, Medicaid, commercial bundled-payment and population health payment programs.

Patrick also represents several medication-assisted treatment (MAT) providers and other substance use disorder (SUD) treatment providers with respect to growth strategy and transactions and regulatory compliance, including telehealth providers and portfolio companies operating on a physician practice management platform.

Prior to practicing law, Patrick obtained a Masters in Health Economics from the London School of Economics and was the senior research assistant for health policy in the Economic Studies Program at The Brookings Institution—a Washington, D.C. think tank consistently ranked as the most influential in the world.

Provides transactional and regulatory counseling to clients in the healthcare and life sciences industries 

Represents investors and their portfolio companies on M&A, joint ventures, and strategic affiliations  

Represents physician practices and other health organizations on corporate, regulatory compliance, and governance matters  

Advises digital health and health tech clients working at the intersection of healthcare, software, analytics, technology, AI, and electronic data 

Travis Jackson advises leading hospitals, health systems, and academic medical centers on their most complex and innovative mergers, acquisitions, affiliations, and joint ventures. He helps both for-profit and nonprofit healthcare organizations bring strategic transactions to market in a way that strengthens operations, improves care delivery, and supports physician and community relationships – while remaining compliant and cost-effective.

Travis has significant experience structuring, negotiating, and implementing transactions designed to advance physician integration, expand clinical offerings, and enhance brand presence. He brings a detailed understanding of federal healthcare reform initiatives, evolving transaction trends, healthcare corporate governance, and other legal issues that shape the business of healthcare.

With deep knowledge of federal tax matters and the distinct challenges facing tax-exempt organizations, Travis is a trusted partner to nonprofit providers navigating the complex state and federal requirements that govern their operations and strategic growth.

Sarah Kitchell focuses her practice on transactional and regulatory matters affecting a wide range of clients in the health care industry, including nonprofit and for-profit health systems, academic medical centers, community hospitals, drug and device manufacturers, contract research organizations, and post-acute and sub-acute providers such as home health and hospice providers, therapy providers, behavioral health providers and senior living facilities.

Sarah concentrates her transactional practice on strategic affiliations, mergers and acquisitions, physician-hospital alignments, venture capital investments and complex contractual arrangements. She also represents research sites, sponsors and contract research organizations with all aspects of clinical research contraction and formation of research networks. She also has provided assistance to medical centers and other research participants involving compliance matters, including internal compliance audits and revisions to policies and procedures involving topics such as research misconduct.

While in law school, Sarah was editor in chief of the Boston University Law Review and served as a summer associate at the Firm. Prior to law school, she worked for the National Cancer Institute’s Cancer Information Service at the University of Iowa Hospitals & Clinics and at a rural health clinic in Tennessee.

Sarah is a member of the Firm’s Associate Development Committee, Associate Recruiting Committee, and Pro Bono and Community Service Committee. She focuses her pro bono efforts on representation of small nonprofit arts organizations and matters for the Medical-Legal Partnership of Boston.

Advises clients on telehealth, remote patient monitoring, AI-enabled tools, consumer wellness and other virtual care or digital health companies on product development, compliance, commercialization, and reimbursement strategies

Guides clients on structuring compliant care delivery models, navigating multi-state licensure, and advising on fraud and abuse, data privacy, cybersecurity, and other key areas

Advises mail order, retail and other types of pharmacies, suppliers and manufacturers on partnerships with healthcare companies and related compliance considerations

Develops compliance frameworks for consumer wellness programs and mobile health solutions

Leads retailers, tech companies and other non-healthcare companies through their development and launch of healthcare products or offerings

Structures provider networks and strategic collaborations among hospitals, health centers, and physicians

Counsels investors on healthcare trends, reimbursement opportunities and changes in laws to assist with designing their investment strategies

Laura McLane co-leads McDermott’s white-collar and government investigations practice as well as the Firm’s False Claims Act (FCA) practice, and is a nationally renowned FCA litigator. For over 25 years, Laura has defended companies touching all aspects of the healthcare and life sciences industries in government investigations, qui tam litigation under the FCA, and related matters. Clients call Laura “an exquisite lawyer, very smart and incisive,” a “fierce advocate for her clients,” and “simply a brilliant attorney with a tremendous ability to navigate difficult circumstances.” (Chambers USA). Laura was named Boston’s Lawyer of Year in Healthcare Litigation by Best Lawyers in America for 2025-2026.

Laura’s experience spans the spectrum of government oversight in healthcare and life sciences. Her clients include healthcare providers of all types as well as laboratories, pharmaceutical and device manufacturers, private equity investors, and an array of other entities that reach the healthcare space. Laura represents clients in FCA matters throughout the country, as well as in federal courts of appeals and the Supreme Court of the United States. She has extensively litigated the myriad issues that typically arise in FCA cases, including representing her client in the landmark Escobar case in the Supreme Court. Clients state that Laura is “fantastic, . . . efficient and able to pull in knowledgeable resources right to the issue” (Legal 500 US) and “Laura is clearly a leader in the FCA space.” (Chambers USA). In addition to her healthcare experience, Laura defends clients facing FCA and other forms of government scrutiny in other industries, such as defense contracting and technology.

Beyond defending clients in investigations and litigation, Laura’s practice includes working closely with clients on FCA risk management and compliance assessments, and counseling buyers and sellers in transactions involving enforcement issues.

Litigates employee mobility, restrictive covenant, and trade secret cases across all industries, including private equity, healthcare, professional services, technology, and manufacturing.

Advises private equity firms and strategic buyers and sellers on employment aspects of M&A transactions, including employment risk assessment and mitigation.

Drafts employment agreements, multijurisdictional restrictive covenants, and termination and separation agreements for nonexempt employees through CEOs.

Counsels employers on noncompete and nonsolicit agreements, employee handbooks and policies, leaves of absence, disability accommodation, and independent contractor relationships

Matt Perreault advises healthcare organizations on complex transactions, sophisticated managed care arrangements, and related fraud and abuse matters. He represents accountable care organizations (ACOs); diverse provider, risk intermediary, care management and provider enablement organizations; health plans; and investors on a wide range of value-based care agreements, including shared savings, bundled payments, downside risk and capitation arrangements.

Matt serves as a strategic advisor to ACOs, independent physician associates (IPAs), managed care networks, integrated delivery networks and other healthcare providers, including hospitals and health systems, specialty providers, physician practices and innovative primary care organizations, on acquisitions, affiliations, reorganizations and other transactions. He also provides guidance on regulatory and fraud and abuse matters related to these transactions and contractual arrangements, including the physician self-referral law (Stark Law), the Anti-Kickback Statute, and general healthcare law and compliance matters.

Prior to joining McDermott Will & Schulte, Matt was deputy general counsel of a large national private health system, where he served as the lead lawyer for its managed care network, multi-specialty physician practice and hospital physician contracting throughout the system.

Tries complex cases in state and federal courts, arbitrations, and other proceedings across healthcare, trade secrets, product and environmental liability, and commercial litigation

Leads the firm’s class action practice, representing plaintiffs and defendants in bet-the-company disputes

Handles appellate matters, including oral argument before federal and state appellate courts across the United States

Maintains an active pro bono practice focused on protecting religious freedom and the rights of children and adults with intellectual and other disabilities

Monica A. Wallace focuses her practice on complex regulatory and transactional counseling to healthcare organizations, including health systems, hospitals, ambulatory surgery centers, physician groups, dental providers, behavioral health clients, integrated delivery systems, academic medical centers, DMEPOS and pharmaceutical manufacturers and suppliers, home health agencies, and venture capital and private equity firms and their health-related portfolio companies. Monica is a practice area leader for the Healthcare Regulatory & Compliance practice.

Monica concentrates her regulatory practice on healthcare fraud and abuse, Medicare and Medicaid enrollment, reimbursement and billing, legal assessments and audits, compliance programs, and other general regulatory matters including licensure, survey/certification and accreditation. Her transactional practice includes mergers, acquisitions and affiliations, divestitures, hospital/physician joint ventures and corporate reorganization.

Previously, Monica worked with hospital executive management at the University of Iowa Hospitals and Clinics on strategic academic medical center issues.

Allison Wilkerson focuses her practice on employee benefits matters. She has extensive experience handling issues pertaining to the Employee Retirement Income Security Act of 1974 (ERISA) and employee stock ownership plans (ESOPs).

With respect to ERISA, Allison focuses on compliance issues and the Internal Revenue Code related to employee benefits, including qualified plans, nonqualified plans, and executive and deferred compensation. While advising employers on the design, implementation and administration of tax-qualified retirement plans and nonqualified retirement plans, Allison provides relevant guidance as to administrative and operational matters, and assists clients with various benefit plan correction programs offered by the Department of Labor (DOL) and Internal Revenue Service (IRS). Allison also has advised employers with respect to issues raised in connection with corporate mergers, acquisitions and divestitures as they relate to the various benefit plans maintained by the affected corporate entity or entities.

Allison focuses her ESOP practice on the design and implementation of ESOP transactions and provides ongoing legal counsel to ESOP-owned companies. She has been involved in hundreds of transactions, including leveraged buyouts, mergers, acquisitions, and the structuring and financing of ESOPs using private equity. She has advised employers on the implementation of nonqualified plans and executive compensation arrangements that complement the employee ownership structure and culture inherent in an ESOP-owned company. Allison also represents independent fiduciaries in their role as purchaser in an ESOP transaction as to their legal duties with respect to their representation of ESOP participants and beneficiaries.

Allison writes and speaks frequently on ERISA and ESOP issues.

Patrick Zanayed represents private equity funds, digital health companies, strategic investors, ambulatory surgery centers, behavioral health facilities, senior care facilities, physician practices, and dental practices in a variety of transactional and regulatory matters. He also has deep experience advising on pharma services, clinical research, and health technology transactions.

Patrick has assisted clients in connection with numerous transactions, including mergers, acquisitions, dissolutions, and management and professional service arrangements, as well as the creation of multi-state physician practice management and telehealth structures. He also regularly advises clients with respect to corporate practice of medicine laws, state and federal telehealth laws, pharmacy laws, the fraud and abuse laws including the Anti-Kickback Statute, Beneficiary Inducements Civil Monetary Penalty Law, the Stark law and other federal and state legal, regulatory and business issues affecting healthcare providers and facilities.

Eric Zimmerman is a recognized Medicare law and policy authority and registered lobbyist who represents clients before Congress and administrative agencies, and helps clients navigate federal legislative and regulatory processes related to Medicare coverage, coding, reimbursement and compliance. He primarily counsels and represents hospitals and health systems, ambulatory surgery centers, clinical laboratories, pharmaceutical, biotechnology and device manufacturers and suppliers, medical trade associations and professional societies.

Leads complex patent litigation disputes, with an emphasis on high-stakes trial work

Represents clients in pharmaceutical and life sciences patent matters, including Hatch-Waxman disputes

Handles patent disputes across a broad range of technologies, including medical devices and consumer products

Advises healthcare providers, from startups to established market leaders, on complex federal and state regulatory and reimbursement matters

Serves as a national authority on the 340B Drug Pricing Program

Counsels clients on fraud and abuse laws, Medicare provider-based and co-location rules, pharmacy laws and licensure, graduate medical education, rural providers, and federally qualified health centers

Advises on the development of innovative healthcare delivery models

Pankit J. Doshi serves as the Office Managing Partner for the firm’s San Francisco and Silicon Valley Office.

Pankit focuses his practice on preventative counseling and representing employers in both state and federal courts up through trial and appeal. Pankit serves as lead counsel on cases involving issues related to prosecution and defense of unfair business competition claims, including trade secret misappropriation and restrictive covenant enforcement, independent contractor misclassification, whistleblower complaints, wage and hour disputes and individual claims for wrongful termination, sexual harassment, discrimination, retaliation and breach of contract claims. Pankit also regularly defends employers in complex wage and hour class action and representative actions around the country.

Pankit provides advice and counseling to employers of all sizes, ranging from Fortune 100 companies to startups, on a full-spectrum of labor and employment issues, among them structuring of restrictive covenants, advising on employment compliance strategies, evaluating independent contractor and exempt status relationships, preparing executive employment agreements and protecting intellectual property. He has also assisted companies with nationwide wage and hour and misclassification audits, as well as highly sensitive workplace harassment investigations.

Pankit is experienced in handling employment matters across numerous industries, including automotive, construction, consulting, entertainment, financial services, healthcare, hospitality, manufacturing, pharmaceuticals, retail, security, technology, telecommunications and transportation.

Pankit represents employers at trial, administrative hearings and during investigations by various state and federal agencies, including the US Department of Labor, the US Equal Employment Opportunity Commission, the California Department of Fair Employment and Housing and the California Department of Industrial Relations – Division of Labor Standards Enforcement.

Pankit frequently lectures at annual meetings on employment law issues around the country.

Diana Douglas focuses her practice on corporate, securities and transactional matters. Diana advises clients on public company reporting and disclosure compliance, public and private offerings of equity and debt securities, mergers and acquisitions, corporate restructurings and commercial transactions. She also counsels clients on general corporate and corporate governance matters.

Diana regularly serves as primary outside counsel for clients.

Diana represents clients from a broad array of industries, including companies in the technology and life sciences sectors.

Paul Gadiock leverages his firsthand experience at the Food and Drug Administration (FDA) to provide life sciences, healthcare and other FDA-regulated companies with practical, strategic counsel at every phase of the product life cycle. Paul supports medical device, digital therapeutic, and biopharma companies, drug compounders, software as a medical device (SaMD) and clinical decision support (CDS) developers, and their investors on their FDA regulatory and due diligence needs, delivering premarket and postmarket regulatory guidance to maximize business outcomes.

From providing strategic regulatory direction at the product concept stage through post-marketing issues such as product marketing, labeling, advertising, and recalls and crisis matters, Paul has substantial experience helping his clients bring novel technologies and innovative products to market and maintain competitive advantages. His deep experience allows him to provide practical, business-minded due diligence support to buyers, sellers and investors in achieving their transaction goals.

As a member of the senior leadership team at the FDA’s Center for Devices and Radiological Health, Paul advised agency officials on issues related to the regulatory scope of the FDA’s policies, programs, regulations, and legislation to the medical device industry. He also collaborated with the Office of Inspector General (OIG) and Government Accountability Office (GAO) on analyses, investigations and oversight of major national programs.

In addition to his government experience, Paul provides a commercially minded approach rooted in real-world experience as a business development executive at a national diagnostic biotechnology company. In that role, he worked with an international team on market entry and regulatory compliance issues to effectively launch and promote products in new market. Prior to joining McDermott Will & Schulte, Paul was a lawyer at several large national law firms.

William (Bill) Gaede is known as one of the foremost intellectual property litigators for the life sciences and medical device industries. He serves as lead counsel for a wide range of companies and research institutes and has extensive experience in litigating life science technologies such as antibodies, proteins, small molecules, and diagnostics.

In addition to his substantial jury trial experience, Bill has argued before the US Court of Appeals for the Federal Circuit. He further provides risk management guidance on freedom to operate issues.

Before entering the private sector, Bill served as the temporary deputy district attorney for the City and County of San Francisco.

Highly experienced advocate with 10 US Supreme Court arguments and 100+ appellate and trial court arguments nationwide

Secures major victories across administrative law, intellectual property, immigration, life sciences, securities, transportation, and energy, including landmark Supreme Court cases

Designs and leads high-impact affirmative litigation, often against federal and state agencies to achieve regulatory and policy wins

Handles complex appeals and challenges to government actions

Margaret J. Sampson, PhD, focuses her practice on global, strategic intellectual property transactions, and patent counseling surrounding the areas of life sciences, pharmaceuticals, research tools, and medical devices. Life sciences and technology clients turn to her for evaluating, structuring, negotiating, and documenting major transactions.

Margaret’s extensive experience includes advising clients in evaluating patent portfolio positions; analyzing freedom-to-operate issues; identifying and evaluating targets for potential investment, mergers, or acquisitions; Hatch-Waxman patent litigation; patent term extensions and adjustments; and patent office proceedings.

She is highly skilled in a variety of transactions such as inbound and outbound licensing and option agreements, development and collaboration agreements, clinical research agreement, clinical and commercial supply agreements, manufacturing agreements, sponsored research agreements, technology transfers, and royalty monetization transactions.

Margaret also has a significant research background, focused on molecular genetics, recombinant DNA and stem cell research, including making mouse knock-out models to better understand the function of genes in an organism.

During law school, Margaret was editor-in-chief of the Texas Intellectual Property Law Journal.

Jiayan Chen is an industry leader on matters relating to health data, technology and research. She represents clients on regulatory and compliance matters, commercial transactions, and investments and acquisitions that require deep knowledge of privacy, data strategies, artificial intelligence (AI) and other healthcare technologies, or research compliance. Clients turn to Jiayan for her practical, industry-informed guidance as they seek to develop, improve, deploy, or acquire solutions or businesses that harness the power of data or technology. Jiayan has extensive experience advising on investments and acquisitions in the life sciences sector, particularly with respect to businesses that conduct clinical research or offer solutions designed to accelerate research or research recruitment. Her practice includes working with patient safety organizations (PSOs) on listing applications, compliance, and strategies for appropriately creating and sharing patient safety work product.

Jiayan’s subject matter and industry insights come from advising a broad range of clients, including AI and other healthcare technology companies; data companies; hospitals and health systems; academic medical centers; genetics companies; digital health companies; PSOs; drug, device, and biotech companies; private equity funds; and platform companies.

Jiayan regularly counsels clients on data privacy requirements under US federal and state privacy law, including the Health Insurance Portability and Accountability Act (HIPAA) and various state genetic, health information, and consumer privacy laws. She works with clients on mapping and implementing data use and sharing strategies with appropriate data governance and programmatic safeguards. Well before the proliferation of generative AI, Jiayan was working with AI developers and deployers on compliance with privacy and research laws, efforts to leverage data to train and validate AI tools, and transactions involving the licensing of AI tools and AI-enabled platforms. These days, Jiayan also guides clients in developing AI governance and advises on proposed regulatory and legislative changes impacting AI.

Jiayan represents clients on a wide array of matters related to biomedical research, including negotiating the full range of agreements impacting research, building research compliance infrastructure, preparing protocols and informed consent and authorizations, and conducting transactions involving research site networks, providers of research solutions and other stakeholders in the biomedical research space. Jiayan’s regulatory practice includes counseling clients on state and federal “sunshine” and gift ban laws. She analyzes proposed arrangements and corporate organizational structures to identify and inform reporting obligations, and helps clients develop compliance mechanisms for managing their reporting obligations.

Provides transactional and regulatory counseling to clients in the healthcare and life sciences industries 

Represents investors and their portfolio companies on M&A, joint ventures, and strategic affiliations  

Represents physician practices and other health organizations on corporate, regulatory compliance, and governance matters  

Advises digital health and health tech clients working at the intersection of healthcare, software, analytics, technology, AI, and electronic data 

Guides development and launch of digital health products and AI-enabled products and services

Structures data use, disclosure, and commercialization strategies for health technology clients

Leads full scale ransomware and other cybersecurity incident remediation and response for private and public companies

Manages government investigations related to privacy, cybersecurity, and consumer protection issues

Advises on HIPAA, HITECH, and health information privacy compliance

Counsels on website and mobile app tracking technologies and wiretapping risk

Mimi Alexandre counsels clients across the healthcare industry with a particular focus on entities in the managed care arena. Mimi routinely works with health plans, health maintenance organizations, private equity funds and vendors, helping them navigate complex regulatory schemes and facilitate business objectives.

Mimi has deep familiarity with and significant experience in government programs, including Medicare Advantage and Part D. She leverages this knowledge to provide risk assessments and practical advice. Mimi also routinely negotiates complex agreements with providers, pharmaceutical benefits managers and risk adjustment vendors. As the managed care landscape shifts, Mimi has gained significant experience evaluating the need for risk-bearing licenses and assisting in the formation of value-based contracting arrangements.

Mimi regularly brings her regulatory knowledge to bear on transactions involving plans, providers, intermediaries and vendors. In this capacity, Mimi evaluates regulatory and business risks for buyers and investors and negotiates deal documents accordingly.

Stacey Callaghan counsels digital health organizations, healthcare entities, and private equity clients as they navigate regulatory, compliance, and transactional issues. She focuses on assisting clients in developing telemedicine strategies and documenting multi-state telehealth arrangements given the evolving digital health regulatory landscape. As co-head of our Women’s Digital Health Initiative, Stacey focuses on aiding digital health providers of women’s health services navigate issues unique to the industry and works to help these clients successfully advance their efforts. Stacey also assists clients in matters including data privacy and protection requirements under HIPAA and other privacy laws, data breach investigations and compliance, and data sharing, licensing, and de-identification arrangements.

Stacey is experienced in executing healthcare transactions, and routinely guides clients through joint ventures, mergers and acquisitions and strategic collaborations. She counsels on governance matters and regulatory issues, including compliance with federal and state fraud and abuse laws.

Prior to joining the firm, Stacey was a healthcare associate at a large US-based law firm. She is a frequent author on a variety of healthcare legal issues, primarily those issues impacting providers in the digital health space. During law school, Stacey served as the executive notes editor for the Journal of Legislation.

James A. Cannatti III advises healthcare, technology, and life sciences organizations on complex regulatory, compliance, and enforcement matters at the forefront of the evolving healthcare ecosystem. His practice spans digital health and health information technology (IT) policy, fraud and abuse compliance, and emerging regulatory risk areas, including in the diagnostics, life sciences services, research, pharmacy, and distribution space.

James counsels healthcare providers, diagnostics companies, health IT developers, and life sciences services and research companies on compliance with federal healthcare requirements, including the Anti-Kickback Statute, Stark Law, and EKRA. He also represents clients in internal investigations and enforcement matters, drawing on his deep experience with government expectations and enforcement priorities to provide practical, regulator-informed guidance on navigating enforcement risk and regulatory change.

James’s advisory work frequently addresses cutting-edge regulatory topics and developments, including:

• Fraud and abuse risk and enforcement trends involving healthcare providers, diagnostics, laboratory services, and life sciences companies
• Internal investigations and responses to government inquiries involving the US Department of Justice and the US Department of Health and Human Services’ Office of Inspector General (OIG)
• Compliance with the Anti-Kickback Statute, Stark Law, and the Eliminating Kickbacks in Recovery Act of 2018 in complex commercial arrangements
• Digital health enforcement and compliance risks, including remote patient monitoring and telehealth
• Information blocking and interoperability requirements under the 21st Century Cures Act
• Health IT certification, APIs, and data-sharing obligations

Before entering private practice, James spent more than a decade at the OIG, where he held a range of roles, including serving as its first Senior Counselor for Health Information Technology. In that role, he worked on the development, interpretation, and enforcement of federal healthcare policy affecting providers, health IT developers, and other industry stakeholders.

While in law school, James served as a managing editor of the Ohio State Journal on Dispute Resolution.

Grayson I. Dimick provides strategic regulatory counseling for a wide variety of healthcare industry members. She delivers creative and practical legal solutions for digital health initiatives that comply with the constantly evolving regulatory landscape.

Grayson counsels healthcare providers, health systems, private equity firms and their portfolio companies, and technology companies on regulatory, transactional and compliance matters. She advises on professional and facility licensure, corporate practice of medicine requirements, professional scope of practice and supervision, prescribing and reimbursement. She also assists clients with the development and implementation of telehealth programs.

Grayson is a member of the Firm’s Gender Diversity Subcommittee and maintains an active pro bono practice.

While in law school, Grayson was a law fellow for Georgetown University Law Center’s first-year legal research and writing program and a senior staff editor for the Food & Drug Law Journal. Prior to law school, she worked for a health policy research center and a behavioral health organization.

Represents companies and individuals in white-collar, litigation, and regulatory enforcement matters, including FCA, FCPA, wire fraud, healthcare fraud, money laundering, and BSA matters

Leads sensitive internal investigations and responds to government inquiries across a range of industries

Tries complex civil and criminal cases and represents clients at all stages of litigation

Advises on compliance program design, implementation, and auditing consistent with DOJ and other applicable guidance

Pankit J. Doshi serves as the Office Managing Partner for the firm’s San Francisco and Silicon Valley Office.

Pankit focuses his practice on preventative counseling and representing employers in both state and federal courts up through trial and appeal. Pankit serves as lead counsel on cases involving issues related to prosecution and defense of unfair business competition claims, including trade secret misappropriation and restrictive covenant enforcement, independent contractor misclassification, whistleblower complaints, wage and hour disputes and individual claims for wrongful termination, sexual harassment, discrimination, retaliation and breach of contract claims. Pankit also regularly defends employers in complex wage and hour class action and representative actions around the country.

Pankit provides advice and counseling to employers of all sizes, ranging from Fortune 100 companies to startups, on a full-spectrum of labor and employment issues, among them structuring of restrictive covenants, advising on employment compliance strategies, evaluating independent contractor and exempt status relationships, preparing executive employment agreements and protecting intellectual property. He has also assisted companies with nationwide wage and hour and misclassification audits, as well as highly sensitive workplace harassment investigations.

Pankit is experienced in handling employment matters across numerous industries, including automotive, construction, consulting, entertainment, financial services, healthcare, hospitality, manufacturing, pharmaceuticals, retail, security, technology, telecommunications and transportation.

Pankit represents employers at trial, administrative hearings and during investigations by various state and federal agencies, including the US Department of Labor, the US Equal Employment Opportunity Commission, the California Department of Fair Employment and Housing and the California Department of Industrial Relations – Division of Labor Standards Enforcement.

Pankit frequently lectures at annual meetings on employment law issues around the country.

Focused on compliance, transactions and sector-specific counseling, Amanda Enyeart works with her clients to deploy digital health technology in compliance with a wide range of health law regulations. She is particularly concentrated on telehealth, fraud and abuse, information technology, data strategies and digital health matters. She provides counsel on all aspects of telehealth and other healthcare delivery modalities, advising on the complex patchwork of state-by-state regulatory issues, including practitioner licensure, Medicare and Medicaid reimbursement, compliance with the federal Stark Law and Anti-Kickback Statute, and state fraud and abuse laws.

Amanda advises healthcare industry clients, including hospitals and health systems, digital health companies, telehealth providers and retail health clinics, on all aspects of software licenses, as well as other agreements, for the acquisition of electronic health record (EHR) systems and other mission critical health information technology. Amanda also counsels healthcare clients, including covered entities and business associates, regarding compliance with the Health Insurance Portability and Accountability Act (HIPAA) and other federal and state privacy, security and breach notification laws.

On the transactional front, Amanda is a valuable resource to companies as they structure business deals and negotiate technology agreements. She is experienced acting on behalf of both technology providers and the healthcare organizations that are their customers. She also conducts specialized due diligence in various health industry areas, including hospitals and health systems, and digital health companies and telehealth companies. In addition, Amanda also regularly acts as counsel in healthcare IT transactional matters concerning telehealth and other mission-critical health information and data-centered technologies.

Assists in the design, deployment, and ongoing implementation of innovative care delivery models for life sciences, healthcare, and informatics clients

Regularly advises companies pivoting to healthcare vertical offerings based on legacy technology and strategic assets

Advises clients on AI governance, public trust, and AI deployment

Advises clients on HIE participation, data sharing and compliance

Counsels clients on the development of data and biospecimen registries, real-world evidence platforms, and biobanking programs

Daniel F. Gottlieb counsels a wide range of healthcare industry clients, including healthcare providers, health plans, health information technology vendors, life sciences companies and data aggregators. He is sought out for his legal knowledge and practical approach on data protection, interoperability, and complex data and software licensing transactions, collaborations and strategic initiatives.

Daniel counsels healthcare clients regarding compliance with US federal and state and international privacy, security, breach notification and information blocking laws, including the Health Insurance Portability and Accountability Act (HIPAA), 21st Century Cures Act, California Consumer Privacy Act (CCPA), Telephone Consumer Protection Act, CAN-SPAM and EU General Data Protection Regulation (GDPR). He offers guidance on the intersection of privacy and security requirements with information blocking prohibitions under the 21st Century Cures Act and Medicare rules impacting the deployment of health information technology.

Daniel has deep experience regarding requirements for de-identification, anonymization and other secondary uses of health information under HIPAA, CCPA and GDPR. Daniel regularly advises clients regarding their response to cyberattacks and other security breaches, and defends against subsequent investigations by state regulators and the US Department of Health and Human Services Office for Civil Rights.

He advises healthcare clients on all aspects of data and software licenses and other agreements for the acquisition of electronic health record (EHR) systems and other mission-critical health IT and health content. He drafts and negotiates hosting, cloud computing and IT service agreements, as well as license agreements for health data and other health content.

Daniel assists with compliance program implementations, compliance audits, and government program overpayment and refund matters, including drafting billing compliance policies and procedures. He also counsels clients on compliance with Medicare and Medicaid reimbursement, fraud and abuse laws; the PhRMA Code on Interactions with Health Care Professionals; and the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

Leads McDermott’s UK Health and Life Sciences Practice Group  

Advises on global M&A and joint ventures across health services, pharma and life sciences, digital health, and health technologies  

Counsels UK and international clients on NHS and public law procurement, regulatory, and contracting matters, including reimbursement and market access  

Advises strategic and private equity investors on transactions and investments in health and life sciences 

Counsels healthcare and life sciences clients on government investigations, regulatory compliance, and compliance program development  

Represents clients in False Claims Act qui tam matters, government audits, civil monetary penalty and exclusion investigations, and CMS suspension and revocation actions  

Advises on the Anti-Kickback Statute and Stark Law, and on Medicare and Medicaid coverage and payment rules  

Negotiates and implements corporate integrity agreements and makes government self-disclosures 

Advises clients on telehealth, remote patient monitoring, AI-enabled tools, consumer wellness and other virtual care or digital health companies on product development, compliance, commercialization, and reimbursement strategies

Guides clients on structuring compliant care delivery models, navigating multi-state licensure, and advising on fraud and abuse, data privacy, cybersecurity, and other key areas

Advises mail order, retail and other types of pharmacies, suppliers and manufacturers on partnerships with healthcare companies and related compliance considerations

Develops compliance frameworks for consumer wellness programs and mobile health solutions

Leads retailers, tech companies and other non-healthcare companies through their development and launch of healthcare products or offerings

Structures provider networks and strategic collaborations among hospitals, health centers, and physicians

Counsels investors on healthcare trends, reimbursement opportunities and changes in laws to assist with designing their investment strategies

Advises clients on trademark and copyright counseling, licensing, prosecution, and enforcement

Helps companies register, maintain, protect, and license trademarks, service marks, domain names, and other brand assets worldwide

Supports business-focused IP planning for transactions, including strategic alliances, joint ventures, M&A, and complex IP license structures

Advises on data-licensing issues, including for clients operating in the digital health space

Serves as first-chair trial counsel in jury trials and arbitrations involving breach of contract, trade secret misappropriation, fraud, breach of fiduciary duty, patent and trademark infringement, False Claims Act, unfair competition, defamation, and deceptive trade practices matters

Advises and represents ultra-high-net-worth families in contentious intrafamily disputes, including guardianship, conservatorship, and trusts and estates battles

Sarah G. Raaii devotes her practice to issues impacting group health and welfare benefit plans by counseling employers, digital health and point solution clients, plan administrators, insurers, consultants and other health plan service providers.

Sarah advises her clients on healthcare reform issues; consumer-driven health benefits; self-funded and fully insured health plans; data privacy and the Health Insurance Portability and Accountability Act (HIPAA); wellness programs; cafeteria plans; and regulatory, sub-regulatory and legal compliance. She provides guidance on the Affordable Care Act (ACA); the Employee Retirement Income Security Act (ERISA); health plan transparency; mental health parity; the No Surprises Act; the Consolidated Omnibus Budget Reconciliation Act (COBRA); flexible benefit plans; health reimbursement accounts (HRAs); health savings accounts (HSAs); plan network design; multiple employer welfare arrangements (MEWAs); association health plans; captive insurance arrangements; and other health benefits issues.

Sarah drafts and negotiates complex agreements between employers, health plans, third-party administrators, pharmacy benefit managers, carriers, consultants and other health plan service providers. She also counsels digital health, telehealth and point solution entities; third-party administrators; pharmacy benefit managers; and other benefit administrators on partnering with employers, group health plans and insurers. As co-chair of the Firm’s Post-Roe Working Group – a multidisciplinary team of lawyers providing clients with reproductive health guidance – Sarah has advised hundreds of health plans and benefit administrators on health benefits following the end of Roe v. Wade.

Additionally, Sarah routinely analyzes frequently changing health benefits laws and regulations and recommends risk mitigation strategies. She provides strategic due diligence and health benefits design, implementation and transition advice on issues arising from corporate and private equity mergers, acquisitions and other transactions.

Sarah frequently publishes and presents on health benefits trends and developments and has been quoted on health plan issues in prominent media outlets, including The New York Times, The Wall Street Journal, Bloomberg Law and Law360.

Prior to joining the firm, Sarah worked at the White House for the National Economic Council, where she implemented the ACA with leaders from the Executive Office of the President, the US Department of Labor, the US Department of Health and Human Services, and the US Department of the Treasury. She previously collaborated with in-house lawyers and federal and state government relations professionals in the leadership development program of a Fortune 500 global insurance and financial services corporation.

Advises companies and individuals in white-collar defense, regulatory enforcement matters, and high-stakes government investigations

Manages sensitive internal investigations across a range of industries and advises on government reporting and remediation

Leads comprehensive incident response teams for companies facing urgent cross-border cybersecurity incidents, ransomware attacks, and AI-related risks

Tries complex civil and criminal cases and represents clients at all stages of litigation

Advises companies and investors across the full ecosystem of FDA-regulated products, including drugs, devices, health technologies, biologics, food, cosmetics, and cannabis  

Provides FDA regulatory counseling from the product concept stage through post-market and product marketing  

Assists clients with FDA-related due diligence in healthcare and life sciences transactions  

Handles the regulatory components of internal investigations, government enforcement, and consumer protection litigation 

Caroline Reignley provides strategic legal, regulatory and compliance counsel to for-profit and nonprofit hospitals, health systems, other healthcare providers, life sciences and technology companies.

Fraud and Abuse

Caroline counsels clients on interpretation and risk mitigation under the Anti-Kickback Statute, Stark Law and EKRA. She also advises on internal and government investigations related to the False Claims Act, Stark Law and Anti-Kickback Statute. Her extensive experience navigating civil and criminal investigations within the healthcare space informs her strategic approach to risk management in transactions and the development of robust compliance programs.

Digital Health

Caroline advises clients involved in digital health—the intersection of health software applications, analytical tools, medical technology and electronic data assets enabled by the internet and mobile devices—on the applicable legal and regulatory infrastructure, with a particular focus on remote patient monitoring programs. She offers nuanced insights into fraud and abuse issues that arise in novel partnerships and other relationships between digital health companies and established healthcare providers. Her broad experience allows her to deliver practical, forward-thinking compliance and revenue strategies that help her clients thrive in today’s complex and still-evolving digital health regulatory landscape.

Medicare Reimbursement and Healthcare Compliance Matters

Caroline advises Medicare providers, consultants and vendors on a wide range of business, legal and regulatory issues. Caroline has extensive experience advising clients on Medicare and Medicaid fee-for-service reimbursement, billing and coding. She also advises clients on professional licensure, scope of practice, physician and health care professional clinician relationships and supervision, together with overall corporate compliance.

Prior to joining the Firm, Caroline served as a health law fellow for a regional nonprofit health system and as a law clerk at the US Department of Health and Human Services. Her background gives her a deep understanding of legal issues from both the regulator and provider perspectives.

Advises companies on cybersecurity incident response, including ransomware attacks, data breaches, fund transfer fraud, and business email compromise

Represents clients in data security and privacy litigation and regulatory investigations

Counsels publicly traded companies on SEC cybersecurity disclosure requirements, including Form 10-K and Form 8-K filings

Leverages a background in computer programming and IT analysis to advise on data security, privacy, AI, and computer forensic investigations

Patrick Zanayed represents private equity funds, digital health companies, strategic investors, ambulatory surgery centers, behavioral health facilities, senior care facilities, physician practices, and dental practices in a variety of transactional and regulatory matters. He also has deep experience advising on pharma services, clinical research, and health technology transactions.

Patrick has assisted clients in connection with numerous transactions, including mergers, acquisitions, dissolutions, and management and professional service arrangements, as well as the creation of multi-state physician practice management and telehealth structures. He also regularly advises clients with respect to corporate practice of medicine laws, state and federal telehealth laws, pharmacy laws, the fraud and abuse laws including the Anti-Kickback Statute, Beneficiary Inducements Civil Monetary Penalty Law, the Stark law and other federal and state legal, regulatory and business issues affecting healthcare providers and facilities.

Advises private equity funds and strategic investors on transactional and regulatory matters in the healthcare services industry  

Represents physician practice management companies and other healthcare services platforms on transactional and regulatory matters.  

Counsels hospital and post-acute provider clients on strategic joint ventures, affiliations, and regulatory matters  

Leads regulatory and transactional matters that shape the health and life sciences landscape

Represents private capital investors across buy-side and sell-side dealmaking in the sector

Helps clients structure innovative strategies with business-focused guidance across borders, and across health and life sciences subsectors

Jiayan Chen is an industry leader on matters relating to health data, technology and research. She represents clients on regulatory and compliance matters, commercial transactions, and investments and acquisitions that require deep knowledge of privacy, data strategies, artificial intelligence (AI) and other healthcare technologies, or research compliance. Clients turn to Jiayan for her practical, industry-informed guidance as they seek to develop, improve, deploy, or acquire solutions or businesses that harness the power of data or technology. Jiayan has extensive experience advising on investments and acquisitions in the life sciences sector, particularly with respect to businesses that conduct clinical research or offer solutions designed to accelerate research or research recruitment. Her practice includes working with patient safety organizations (PSOs) on listing applications, compliance, and strategies for appropriately creating and sharing patient safety work product.

Jiayan’s subject matter and industry insights come from advising a broad range of clients, including AI and other healthcare technology companies; data companies; hospitals and health systems; academic medical centers; genetics companies; digital health companies; PSOs; drug, device, and biotech companies; private equity funds; and platform companies.

Jiayan regularly counsels clients on data privacy requirements under US federal and state privacy law, including the Health Insurance Portability and Accountability Act (HIPAA) and various state genetic, health information, and consumer privacy laws. She works with clients on mapping and implementing data use and sharing strategies with appropriate data governance and programmatic safeguards. Well before the proliferation of generative AI, Jiayan was working with AI developers and deployers on compliance with privacy and research laws, efforts to leverage data to train and validate AI tools, and transactions involving the licensing of AI tools and AI-enabled platforms. These days, Jiayan also guides clients in developing AI governance and advises on proposed regulatory and legislative changes impacting AI.

Jiayan represents clients on a wide array of matters related to biomedical research, including negotiating the full range of agreements impacting research, building research compliance infrastructure, preparing protocols and informed consent and authorizations, and conducting transactions involving research site networks, providers of research solutions and other stakeholders in the biomedical research space. Jiayan’s regulatory practice includes counseling clients on state and federal “sunshine” and gift ban laws. She analyzes proposed arrangements and corporate organizational structures to identify and inform reporting obligations, and helps clients develop compliance mechanisms for managing their reporting obligations.

Paul Gadiock leverages his firsthand experience at the Food and Drug Administration (FDA) to provide life sciences, healthcare and other FDA-regulated companies with practical, strategic counsel at every phase of the product life cycle. Paul supports medical device, digital therapeutic, and biopharma companies, drug compounders, software as a medical device (SaMD) and clinical decision support (CDS) developers, and their investors on their FDA regulatory and due diligence needs, delivering premarket and postmarket regulatory guidance to maximize business outcomes.

From providing strategic regulatory direction at the product concept stage through post-marketing issues such as product marketing, labeling, advertising, and recalls and crisis matters, Paul has substantial experience helping his clients bring novel technologies and innovative products to market and maintain competitive advantages. His deep experience allows him to provide practical, business-minded due diligence support to buyers, sellers and investors in achieving their transaction goals.

As a member of the senior leadership team at the FDA’s Center for Devices and Radiological Health, Paul advised agency officials on issues related to the regulatory scope of the FDA’s policies, programs, regulations, and legislation to the medical device industry. He also collaborated with the Office of Inspector General (OIG) and Government Accountability Office (GAO) on analyses, investigations and oversight of major national programs.

In addition to his government experience, Paul provides a commercially minded approach rooted in real-world experience as a business development executive at a national diagnostic biotechnology company. In that role, he worked with an international team on market entry and regulatory compliance issues to effectively launch and promote products in new market. Prior to joining McDermott Will & Schulte, Paul was a lawyer at several large national law firms.

Assists in the design, deployment, and ongoing implementation of innovative care delivery models for life sciences, healthcare, and informatics clients

Regularly advises companies pivoting to healthcare vertical offerings based on legacy technology and strategic assets

Advises clients on AI governance, public trust, and AI deployment

Advises clients on HIE participation, data sharing and compliance

Counsels clients on the development of data and biospecimen registries, real-world evidence platforms, and biobanking programs

Advises companies and investors across the full ecosystem of FDA-regulated products, including drugs, devices, health technologies, biologics, food, cosmetics, and cannabis  

Provides FDA regulatory counseling from the product concept stage through post-market and product marketing  

Assists clients with FDA-related due diligence in healthcare and life sciences transactions  

Handles the regulatory components of internal investigations, government enforcement, and consumer protection litigation