Our FDA and Life Sciences team guides companies through all aspects of U.S. and EU regulatory compliance challenges. We work through every issue at every stage of a product’s life cycle.
Manufacturers, investors, and other regulated entities value our practical advice and relationships with regulators (including FDA; CMS; U.S. Congress; DOJ; U.S. Attorney’s Offices; DEA; OCR; VA; State Boards of Pharmacy; State Attorneys General; the European Commission; Notified Bodies in the European Union; the European Medicines Agency; the European Food Safety Authority; and the European National Competent Authorities). The team’s 40+ lawyers and consultants have held senior positions in government, industry, academia and the medical profession. Through benchmarking from our over 250 industry clients, our annual West Coast Pharmaceutical and Medical Device University, Medical Device Summit and Pharmaceutical University, and cutting-edge webinars and client alerts, our attorneys share and analyze key developments and practical insights on the most relevant issues in the life sciences space.
Regulation has posed increased challenges for the life sciences industry. Companies now face a changing political landscape. Our dedicated team is ready to assist with client-focused advice based on years of industry experience.
We work with companies regulated by the FDA, including in pharmaceuticals, biotech, devices, food, supplements, cosmetics and tobacco. We address every type of legal issue touched by federal, state or EU regulation for every type of company, from seeding start-ups, to mergers and acquisitions, to IPOs, to product approvals, to pricing and coverage, to inspections, to investigations, to lobbying agencies and legislatures.
We are distinguished by our outstanding attorneys, but also by our industry specialist consultants, including physicians and former senior FDA officials focused on quality and safety, good manufacturing practices, inspections and product approvals. Our consultants work under privileged legal supervision to provide companies with integrated medical and technical assessments and recommendations, including for FDA interfaces, meetings and submissions; system audits and mock inspections; and crisis management.
Our team in the EU focuses on EU and national (French, Belgian and German) issues associated with the legal requirements of the pharmaceutical, biologic, medical device, cosmetic and food industries. They advise life sciences clients on successful strategies for addressing significant EU policy developments and the EU regulatory regimes. The EU team represents our clients in litigation cases before German and European courts, including the General Court and the Court of Justice of the European Union, and in investigations.
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Marisa Maleck is profiled as a Law360 Rising Star