Monica R. Chmielewski is a member of the Health & Life Sciences Group and has more than 25 years of experience in life sciences, food and drug law, healthcare, pharmacy, and supply chain matters. She advises pharmaceuticals, biotech and medical device companies, health systems, academic medical centers, hospitals, physician groups, manufacturers and distributors, and pharmacies on regulatory compliance; transactional matters; clinical research; grants, grant administration, and compliance; product development and commercialization; and sourcing, manufacturing, and distribution issues. Her practice encompasses the full spectrum of life sciences and healthcare law, including clinical trial compliance, conduct and regulation, the structure and conduct of decentralized clinical trials, US Food and Drug Administration submissions and approvals, pharmaceutical and medical device manufacturing, licensing and commercialization, virtual care compliance, and corporate integrity matters.
Drawing on her experience serving as in-house regulatory and compliance counsel for an international pharmaceutical company and a large national health system, Monica has an in-depth understanding of the regulatory requirements and operational details of clinical research, new product approvals, and the commercialization of products. She provides comprehensive counsel across the full spectrum of regulatory and compliance issues faced by entities in the life sciences and healthcare space, including providing guidance on clinical research and development operations; institutional review board governance; research misconduct investigations; federal grants; research compliance programs; good clinical practice standards; government audits and investigations; the Food, Drug, and Cosmetic Act; and fraud and abuse laws. She helps clients navigate the regulatory landscape when developing and commercializing products and advises on medical device and pharmaceutical product promotion and off-label marketing compliance, premarket approval applications, investigational new drug applications, investigational device exemptions, new drug and 510(k) applications, software as a medical device regulation, artificial intelligence-enabled solutions, and mobile health applications.
Monica’s supply chain practice is a cornerstone of her work, with extensive experience representing manufacturers, pharmacies, and healthcare entities on drug and device pricing negotiations, procurement matters, and supply chain management. She counsels on group purchasing organization formation and negotiation, pharmacy benefit manager (PBM) contracting and audits, and customs import/export compliance. She advises health plans on PBM procurement for mail, retail, specialty drug services, and represents retail and specialty pharmacies on state board compliance, compounding matters, and licensure issues.
Additionally, Monica has extensive transactional experience, having served as counsel on mergers; acquisitions; and sales of hospitals, pharmacies, contract research organizations, physician-owned surgery centers, health systems, and physician practices. She advises venture capital and private equity investors on acquisitions and exits and counsels on joint ventures, ancillary services formation, and recapitalizations. She also advises clients on regulated product development and commercialization, including manufacturing, licensing, collaboration, and distribution arrangements.
Monica’s corporate compliance practice includes designing and implementing compliance programs; conducting compliance training; coordinating internal investigations; and advising on False Claims Act, Stark Law, Anti-Kickback Statute, Health Insurance Portability and Accountability Act, and Civil Monetary Penalties compliance. She also advises healthcare entities and providers on virtual care structuring, professional services agreements, and regulatory policy development.
Previously, Monica served as senior director and senior legal counsel at Ascension Health, the nation’s largest Catholic nonprofit health system. She also served as in-house legal regulatory and compliance counsel at Takeda Pharmaceuticals North America.
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