Healthcare: Pharmaceutical/Medical Products Regulatory
USA Guide 2024 : District of Columbia
Band 1
Contact number
202 662 6000Chambers Review
Covington & Burling LLP is a powerhouse in the pharmaceutical and medical device industry with extensive experience advising on product development, manufacturing and pharmacovigilance. Retained by clients for its proficiency dealing with regulatory bodies, including the FDA and Consumer Product Safety Commission.
Work Highlights
- Covington & Burling LLP successfully advised Astellas on the successful submission of a New Drug Application for Veozah.
Strengths
Provided by Chambers
"Covington provides outstanding support on complex and sophisticated matters."
"Covington has an expert in every significant area. The team has excellent responsiveness and a sense of urgency."
"Covington provides outstanding support on complex and sophisticated matters."
"Covington has an expert in every significant area. The team has excellent responsiveness and a sense of urgency."
Notable Practitioners
Peter Safir is a seasoned regulatory practitioner with impressive strength across a range of FDA mandates. His expertise includes enforcement proceedings and investigations.
"Peter is an excellent lawyer."
Michael Labson is a preeminent regulatory expert with notable strength in advising on compliance and contentious FDA proceedings. He routinely handles transactions and investigations on behalf of prominent life sciences companies.
Denise Esposito handles a wide range of issues for pharmaceutical and biotechnology companies, including the development and promotion of new drugs and digital health products.
"Denise is a terrific lawyer."
Krista Hessler Carver maintains a broad FDA regulatory practice that includes advocating for policy changes. She counsels a variety of companies on complex matters, including responses to the Inflation Reduction Act.
"Krista has a great depth of experience."
Pamela Forrest is an experienced attorney who focuses her practice on medical device issues. She is routinely called upon to advise clients on FDA enforcement actions and warning letters, among other matters.
"Pam is a great lawyer."
"She is a very good technical lawyer."