Regulation has posed increased challenges for the life sciences industry. Companies now face a changing political landscape. Our FDA and Life Sciences team guides companies regulated by the FDA, including in pharmaceuticals, biotech, devices, food, supplements, cosmetics. and tobacco, through all aspects of U.S. and EU regulatory compliance challenges. We draw on years of industry experience to 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 U.S. state, federal and EU regulatory bodies. The team’s 40+ lawyers and consultants have held senior positions in government, industry, academia and the medical profession. Through benchmarking from over 300 industry clients, our annual marquee conferences, 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.
We are distinguished not only by our outstanding attorneys, but also by our industry 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.
K&S launches General Counsel Internal Investigations Decision Tree for the Life Sciences industry, including COVID-19 considerations.explore here
U.S. News & World Report
U.S. News and World Report
LMG Life Sciences
Legal 500, 2020-2021, 2023
November 20, 2023
Heather Banuelos discusses the FDA’s final rule on the presentation of the "major statement" about a prescription drug's side effects and contraindications in direct-to-consumer television and radio ads