Pharmaceuticals and Biologics

AGG’s Food and Drug Practice Team works with pharmaceutical and biologics companies. It is the largest practice devoted solely to FDA counseling in the Southeast, with offices also in Washington, D.C., is known for its pragmatic, creative, and cost-efficient approach to solving problems.  AGG lawyers work with companies to identify potential regulatory and business challenges and help overcome these possible obstacles.  Our lawyers provide value in a cost-efficient manner, balancing regulatory objectives with real-world business considerations.  Its clients include pharmaceutical and biologic companies of all sizes, start-up to multinational businesses, many traded on NYSE, NASDAQ, and other foreign-trading exchanges. 

Our client base covers innovator and generic companies, prescription and over-the-counter, representing all therapeutic areas.  AGG advises a wide variety of pharmaceutical companies, including those developing orphan drugs, preparing 505(b)(2) or abbreviated new drug applications, and pursuing combination products.  AGG lawyers work with companies to understand and navigate the FDA regulatory process from initial clinical trial development to product approval, product promotion, post-approval requirements, and management.

Working with scientific and medical experts, AGG lawyers assist pharmaceutical and biotechnology companies in preparing full new drug applications, hybrid 505(b)(2) NDAs, and ANDAs, Biologic License Applications, and investigational new drug applications, and responding to Federal and State compliance and enforcement issues. We counsel on combination products and on related issues that affect the industry, such as privacy, fraud and abuse, state gift reporting, import and export matters, and patents, trademarks and copyright laws.

In addition to its consultation on all FDA-related matters, AGG advises clients on regulatory matters involving the Drug Enforcement Administration, the Federal Trade Commission (FTC), the Consumer Product Safety Commission, as well as State Boards of Pharmacy and other state regulatory bodies.

AGG lawyers are committed to the pharmaceutical and biologic industries and currently serve as General Counsel to the PDMA Alliance, Inc., founding Members of Georgia Bio (Georgia’s Life Science trade association), as teachers of food and drug law at Emory University School of Law, and as lecturers at programs sponsored by the Food and Drug Law Institute and the Regulatory Affairs Professionals Society.  Its members also serve on the Editorial Boards of three national FDA and regulatory periodicals, and on the Board of the National Health Museum.