Regulation has posed increased challenges for the life sciences industry. Companies now face a changing political landscape. Our dedicated team of subject matter experts is ready to assist with client-focused advice based on years of industry experience.

We specialize in working 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.