Healthcare: Pharmaceutical/Medical Products Regulatory
USA Guide 2024 : District of Columbia
Band 1
Contact number
+1 202 736 8000About
Provided by Sidley Austin LLP
For more information on the practice, please visit the practice's page at: https://www.sidley.com/en/services/healthcare
Chambers Review
Sidley Austin is a multitalented team that attracts an impressive breadth of work in the sector, representing both healthcare providers and manufacturers in relation to complex clinical matters, including research trial compliance. It advises on an array of regulatory issues including pricing, reimbursement and coverage. The firm is frequently retained on high-stakes government investigations, with experience across criminal and civil matters.
Work Highlights
- Sidley Austin provided FDA advice to Ferring Pharmaceuticals on the Biologics License Application process.
Strengths
Provided by Chambers
"Sidley has an impressive team with an impressive breadth of knowledge."
"Its practitioners are very aware of what is happening in the industry and commercial market."
"Sidley has an impressive team with an impressive breadth of knowledge."
"Its practitioners are very aware of what is happening in the industry and commercial market."
Notable Practitioners
Raymond Bonner is a regulatory practitioner with notable FDA capabilities. He often advises multinational drug companies on manufacturing and quality control concerns.
Rebecca Wood has extensive knowledge of FDA regulations and provides counsel for a range of clients, including pharmaceutical, device and diagnostic manufacturers. Her expertise encompasses fraud and abuse cases and privacy matters.
"Rebecca is a pleasure to work with."
"She is an excellent lawyer."
Brenna Jenny has built an impressive practice that focuses on advising clients on investigations, government enforcement and a range of regulatory compliance issues.
"Brenna is fantastic - she is very knowledgeable in healthcare regulatory space."
"She is an extremely talented lawyer. She is thorough, strategic and insightful."
Deeona Gaskin is an up-and-coming expert in pharmaceutical and medical device law. She has experience in a variety of FDA inspection and compliance work.
"Deeona is a pleasure to work with and always goes the extra mile to ensure that our legal needs are met in a timely and thorough way."
"Deeona is extremely knowledgeable, has deep experience and is always a pleasure to work with."
James Johnson advises clients on complex FDA regulatory matters, including data privacy issues and inspections. He is very strong at advising on good manufacturing practice.
"Jim is great in the GMP space."
Mark Langdon has a broad range of expertise in healthcare. He has notable experience handling matters relating to the Anti-Kickback Statute and False Claims Act, as well as healthcare transactions. His client base is comprised of providers, pharmacies and medical device manufacturers.
Raj Pai is held in high regard for his ability to assist clients on regulatory issues related to manufacturing sites, as well as compliance with the Drug Supply Chain Security Act.
"He is an excellent lawyer - he is very practical, solution-oriented and able to deliver advice that is timely and implementable."
Ranked Lawyers at
Sidley Austin LLP
District of Columbia
Members
Provided by Sidley Austin LLP