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Capabilities

FDA and Life Sciences

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.

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March 11, 2024
Health Headlines March 11, 2024

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March 4, 2024
Health Headlines March 4, 2024

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February 26, 2024
Health Headlines February 26, 2024

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Named “Law Firm of the Year” for FDA Law


U.S. News & World Report

Named ‘Practice Group of the Year’ for the Life Sciences Practice


Law360, 2016-2019

Ranked Tier 1 (National and in DC) for FDA Law


U.S. News and World Report

LMG Life Sciences named 20 K&S lawyers as “Life Sciences Stars” in the 2019 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

Ranked as one of the leading firms in Pharmaceutical and Medical Products Regulatory


Chambers USA

Named Medical Device "Firm of the Year"


LMG Life Sciences

Selected as a leading firm in the nation in the Life Sciences industry


Legal 500

Tier 1 for Product Liability, Mass Tort and Class Actions: Defense – Pharmaceuticals and Medical Devices


Legal 500, 2020-2021, 2023

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Recognition

Named “Law Firm of the Year” for FDA Law


U.S. News & World Report

Named ‘Practice Group of the Year’ for the Life Sciences Practice


Law360, 2016-2019

Ranked Tier 1 (National and in DC) for FDA Law


U.S. News and World Report

LMG Life Sciences named 20 K&S lawyers as “Life Sciences Stars” in the 2019 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

Ranked as one of the leading firms in Pharmaceutical and Medical Products Regulatory


Chambers USA

Named Medical Device "Firm of the Year"


LMG Life Sciences

Selected as a leading firm in the nation in the Life Sciences industry


Legal 500

Tier 1 for Product Liability, Mass Tort and Class Actions: Defense – Pharmaceuticals and Medical Devices


Legal 500, 2020-2021, 2023