Our FDA & Life Sciences practice is at the forefront of the legal, regulatory, and policy issues shaping all FDA‑regulated companies, advising on their most complex, business‑critical challenges. Our experience extends throughout the full product lifecycle – from clinical trials and product approval to post-market compliance, product recalls, FDA inspections, product risk assessments, reimbursement, investigations and FDA/DOJ enforcement, and business disputes.

Based across the U.S. and Europe, our team serves pharmaceutical, biologic, medical device, diagnostic, food and beverage, dietary supplement, cosmetic, pharmacy and laboratory clients, ranging from emerging companies to global industry leaders. Manufacturers, investors, and other regulated entities rely on us for practical, strategic advice grounded in a deep understanding of their operations, risk profile and commercial objectives. 

Our practice is distinguished by its deep bench of former senior government officials that leverage insights into agency decision-making processes at the FDA, CMS, HHS, DOJ, DEA and related agencies. Our team includes expert industry consultants, including physicians and former FDA professionals, work under privileged legal supervision to provide integrated medical, scientific, and regulatory assessments and advice. Our integrated support allows clients to manage regulatory risk in the context of evolving market demands and policy priorities.

Our European team advises on EU‑wide and national regulatory regimes, including French, Belgian, and German requirements, and represents life sciences clients in investigations and litigation before German and European courts, including the General Court and the Court of Justice of the European Union.