Life Sciences: Regulatory/Compliance

Peter Safir has extensive experience handling food and drug regulatory issues throughout the US, with a particular concentration on pharmaceuticals. His practice covers a variety of different types of work, including drug quality issues, market practices and life cycle management.

Richard Kingham advises US and European biotech businesses, trade associations and pharmaceutical manufacturers on domestic and international regulatory requirements. His work typically ranges from biosimilars policy counsel to Congressional hearings and administrative investigations.

John Hurvitz is skilled at advising businesses on both transactions and strategic matters such as dispute resolution, industry best practice and benchmarking, asset management and business development.

Michael Labson counsels biotech and pharmaceutical clients on their compliance and relationships with the regulatory agencies.

Denise Esposito draws on substantial government and in-house experience to advise life sciences businesses on matters of strategy, policy and regulatory compliance.

"Denise gives effective strategic and practical advice. She is tremendously responsive and an excellent partner."

Emily Leonard advises clients on matters including licensing and technology transfers, joint ventures and strategic partnerships, as well as research and operations-related commercial agreements.

George Pappas is a patent litigator and trial lawyer with a client roster drawn from pharmaceuticals, medical devices and biotech as well as complementary areas such as software and electronics.

Krista Hessler Carver counsels pharmaceutical and biotechnology businesses on legislative and regulatory developments and procedure, including Hatch-Waxman compliance, life cycle management, digital health and orphan drugs.

"Krista is very experienced and knowledgeable. She is able to take a complex set of issues and translates them into understandable English."

"Her analysis is very clear and she is a wicked smart lawyer."