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 50+ 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 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.
February 11, 2019
Health Headlines – February 11, 2019
February 4, 2019
Health Headlines – February 4, 2019
U.S. News & World Report
U.S. News and World Report
LMG Life Sciences
January 25, 2019
Lisa Dwyer quoted on the effect of the shutdown on the FDA