Life Sciences: Regulatory/Compliance

AGG's FDA-regulated clients include pharmaceutical, medical device, food, cosmetic, and biologic companies of all sizes, from start-ups to multinational businesses, many of which are traded on the NYSE, NASDAQ, and foreign trading exchanges. We work with companies representing all therapeutic and consumer product areas.

With a client base of hundreds of companies throughout the United States and a number based outside of the U.S., we are known for our pragmatic, creative, and cost-efficient approach to client work. In addition, with lawyers on our team who previously worked at the Food and Drug Administration, we are able to provide clients with an insiders’ view of the regulatory process. We pride ourselves on balancing regulatory objectives with each client’s real-world business considerations to identify and implement the best holistic solution possible.

We help companies navigate the FDA-regulatory process from initial clinical trial development to product approval, product promotion, post-approval requirements, and management. Our attorneys also help clients with corporate transactions involving FDA-regulated products. Additionally, we advise clients with federal and state compliance and enforcement issues, and we counsel on related issues that affect the industry, such as privacy, fraud and abuse, state gift reporting, and trademarks and copyright laws.