Life Sciences FDA, Global Regulatory & Market Access
Overview
Whether you’re a global biopharma leader in medical devices and drugs, a cutting-edge digital health innovator, a clinical research organization or something completely new, our Food and Drug Administration (FDA) practice will help fuel your mission by guiding you through the complex regulatory and compliance landscape.
As the top-ranked law firm for health and a leader in life sciences, we are dedicated to our clients and passionate about the work we do together. We counsel clients on the development, manufacture, marketing and promotion, and reimbursement of drugs, biologics, devices and other products regulated by the FDA.
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Results
- Advising the digital health business unit and regulatory team of one of the world’s leading independent biotechnology companies on FDA regulatory matters related to the development of digital health solutions, including mobile applications and software; we help the company evaluate regulatory pathways for innovative products to enter the market, manage post-market compliance issues for new products that combine biopharmaceuticals, digital technology and health IT solutions, and address related issues on the cutting edge of personalized medicine and innovative therapies
- Advising a global genomic-based clinical laboratory services company in the development and implementation of government strategies to address FDA regulatory and Medicare reimbursement issues for their laboratory tests, including advising on compliance and fraud and abuse issues in the current environment of heightened scrutiny
- Advising a biopharmaceutical and medical device company and its research and development arm on a range of regulatory issues related to the development and marketing of drugs and medical devices
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