Life Sciences: Regulatory/Compliance
USA Guide 2024 : USA - Nationwide
Band 1
Contact number
202 662 6000Chambers Review
Covington & Burling LLP is sought after for the quality of its regulatory advice on a range of issues including pharmacovigilance, good manufacturing practices and post-approval compliance. The firm is recommended for contentious patent matters including infringement, ANDA and Hatch-Waxman proceedings. It has a wealth of experience assisting with strategic partnership formations and M&A, as well as venture fund investments and spinoff formations.
Work Highlights
- Covington & Burling LLP continued to serve as outside counsel to the Pharmaceutical Research and Manufacturers of America (PhRMA) on a range of life sciences regulatory, policy and legislative issues. This included supporting PhRMA in connection with legislation regarding drug pricing in the Inflation Reduction act.
Strengths
Provided by Chambers
"Covington is a regulatory powerhouse."
"The Covington team is impeccable in its client service. The attorneys are thorough and innovative in thinking about complex transaction types."
"Covington is a great firm. It's a one-stop shop with broad global coverage and subject area expertise."
"Covington is a regulatory powerhouse."
"The Covington team is impeccable in its client service. The attorneys are thorough and innovative in thinking about complex transaction types."
"Covington is a great firm. It's a one-stop shop with broad global coverage and subject area expertise."
Notable Practitioners
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.
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.
"Richard is the grandfather of FDA law."
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.
"I appreciate his level of expertise, intellectual approach and ability to capture nuances. His drafting skills are also amazing."
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.
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.
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.
Ranked Lawyers at
Covington & Burling LLP
USA - Nationwide