Life Sciences: Regulatory/Compliance
USA Guide 2024 : USA - Nationwide
Band 1
Contact number
+1 202 637 5600About
Provided by Hogan Lovells
Navigating complexities in the life sciences and health care industries is no easy task. Successfully competing in the space requires increasingly creative strategies and integrated solutions that protect and support your business day in and day out.
Regardless of the sector of the health care industry you operate or the maturity of your products, we understand how to bridge the gap between the challenges you face and the outcome you want. From budding startups to multinational enterprises, we've been there before and know how to position you for success.
With more than 500 life sciences and health care lawyers across the globe, we work closely with you and each other to tackle tough issues and difficult-to enter markets - no matter where you are today or want to be tomorrow. And because we know what makes your industry tick, we have a deep understanding of the issues you face - helping you stay ahead of the curve and on top of your opportunities.
Whatever your challenge, wherever the issue, Hogan Lovells has you covered.
Chambers Review
Hogan Lovells enjoys a strong reputation for its roster of regulatory attorneys who offer guidance on compliance, approval processes and contentious engagements with government agencies. The firm has additional expertise in pharmaceutical and medical device product liability proceedings. It also advises on business development, clinical trials, capital markets transactions and strategic partnerships.
Work Highlights
- Hogan Lovells worked with Novartis to secure new chemical entity exclusivity for their product Entresto.
Notable Practitioners
David Fox is well versed in FDA review procedures for new products and Hatch-Waxman compliance issues. He offers further experience in related intellectual property matters and product life cycle management.
"David has a really unique understanding of the FDA."
Philip Katz is a seasoned guide for startups and public companies in the biotech and pharmaceuticals industries, frequently assisting clients in the navigation of FDA and other regulatory frameworks. He is well versed in Hatch-Waxman, orphan drug and biosimilars issues and is adept at representing clients in court and before various regulators.
Ranked Lawyers at
Hogan Lovells
USA - Nationwide
Members
Provided by Hogan Lovells
Andrew Strong
Arne Thiermann
Beth Roberts
Calvin Ding
Christian Di Mauro
Cullen Taylor
Frederick Ch'en
Hein van den Bos
Jane Summerfield
Head of Department
Jodi Scott
Joy Sturm
Julie Schindel
Kristin Connarn
Lauren Battaglia
Lu Zhou
Maria Durant
Mehler Lynn
Head of Department
Randy Prebula
Head of Department
Industries
Provided by Hogan Lovells
Cell, tissue, and Gene Therapies
Clinical Trials
Digital Health and AI
Healthcare Services
Hospitals and Healthcare Providers
Licensing and Commercial Transactions
Medical Devices
Pharmaceutical and Biotechnology