Our 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. Merely as examples, our lawyers work on orphan drug matters, Breakthrough Therapy Designation requests, clinical trial agreements, quality agreement reviews, import/export issues, Citizen Petition inquiries or market exclusivity and patent certification questions, pharmacy compounding issues, combination product jurisdictional questions, and Good Manufacturing Practice-compliance matters.
Our attorneys help clients with corporate transactions involving FDA-regulated products. We prepare Regulatory Opinion Letters for securities filing and those regulatory sections involving FDA regulation and regulatory risks. We also conduct due diligence on potential investments, product or company acquisitions, co-promotion, licensing and distribution agreements, and other commercial transactions.
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. Clients also trust our advice on regulatory matters involving the Drug Enforcement Administration, the Federal Trade Commission, as well as State Boards of Pharmacy, and other state regulatory bodies.
We have decades-long strong relationships with FDA-regulated industries, and we are committed to maintaining these relationships for decades to come. We currently serve as general counsel to the Sharing Alliance, Inc. and as counsel to the Natural Products Association. Our attorneys are founding members of Georgia Bio (Georgia’s life sciences trade association) and lecture at universities and programs sponsored by the Food and Drug Law Institute and the Regulatory Affairs Professionals Society. In addition, our attorneys serve on the editorial boards of three national FDA and regulatory periodicals and on the board of the National Health Museum. We are also recognized by leading rankings institutions, including Chambers USA, LMG Life Sciences, Who’s Who in Legal Life Science, and The Best Lawyers in America®.