Provided by Arnall Golden Gregory LLP
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.
Provided by Chambers
Arnall Golden Gregory obtained approval for an over-the-counter drug company
for its generic Omeprazole drug product.
Provided by Chambers
They almost instantaneously capture all intricacies involved and propose best paths forward with respective risk assessments.
What sets AGG apart is the level of accessibility and responsiveness they provide: it feels like I have a general counsel right next door at all times.
They have expertise in FDA pharmaceutical regulations and FDA processes, and are responsive to company needs and timelines.
The firm has consistently provided us with excellent legal support.
They almost instantaneously capture all intricacies involved and propose best paths forward with respective risk assessments.
What sets AGG apart is the level of accessibility and responsiveness they provide: it feels like I have a general counsel right next door at all times.
They have expertise in FDA pharmaceutical regulations and FDA processes, and are responsive to company needs and timelines.
The firm has consistently provided us with excellent legal support.
Provided by Chambers
Alan is very responsive and quickly able to understand the issues at stake and provide sound practical legal advice to address such issues.
Alan has a remarkable ability to distill complex issues into clear, actionable strategies that mitigate risk.
Alan is highly accessible and possesses extensive knowledge across a broad range of legal and regulatory matters.
Alan has been an invaluable resource for us and I would recommend him without hesitation.
Provided by Arnall Golden Gregory LLP
Head of Department
Gabriel H. Scannapieco
Head of Department