FDA and Life Sciences

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 specialists 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 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.

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Practice Lawyers

Mark S. Brown
Washington, D.C.

Seth H. Lundy
Washington, D.C.

Ulf H. Grundmann

Elaine H. Tseng
San Francisco

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Named “Law Firm of the Year” for FDA Law

U.S. News & World Report, 2014, 2016 and 2018

Named a Life Sciences "Practice Group of the Year"

Law360, 2016 & 2017

LMG Life Sciences named 14 K&S lawyers as "Life Sciences Stars" in the 2017 edition

K&S Frankfurt team recognized in pharmaceuticals, medical products & food law

JUVE Handbook

Food practice ranked as one of the leading practices in the nation

Chambers USA, 2017

Named Medical Device "Firm of the Year"

LMG Life Sciences