Life Sciences: Regulatory/Compliance
Global Guide 2024 : USA
Band 1
Contact number
+1 202 637 5600Chambers Review
Hogan Lovells is an internationally oriented firm which combines a well-established presence in the USA and an impressive network of offices in other key jurisdictions throughout Europe, Asia, Australia, the Middle East and Africa. The firm's US presence remains an important contributor to its worldwide success and provides a strong transatlantic platform through frequent collaboration with the firm's London office. Washington, DC serves as a key location for the firm's international trade and arbitration practice, while the firm's US-based lawyers also play a significant role in coordinating cross-border advice on regulated industries and M&A transactions.
Life sciences is a key industry for the firm's global platform, and clients are often attracted to working with the firm due to its capacity to provide a high level of specialism towards the sector across numerous countries. The firm's typical clients include companies developing and distributing medical devices and pharmaceutical giants, with the firm acting on IP matters, product liability, regulatory issues and a range of cross-border litigation. Due to the strength of the firm's European offices, issues connecting the USA and Europe are common in the team's work.
Strengths
Provided by Chambers
"Hogan Lovells fields experts from different offices and disciplines necessary to address our issues."
"Hogan Lovells fields experts from different offices and disciplines necessary to address our issues."
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.
Philip Katz is a seasoned guide for start-ups 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.