The experienced Food & Drug Administration (FDA) Regulatory Group attorneys at Eckert Seamans counsel and advise clients on food, drug, biologic, and medical device development as well as other regulatory matters that are subject to the jurisdiction of the FDA. Obtaining FDA approval and launching new products into the market can present a daunting array of challenges and opportunities. Eckert Seamans’ FDA Regulatory team has developed an integrated approach that enables clients to achieve and maintain regulatory compliance while developing and marketing FDA-regulated products.

Eckert Seamans’ FDA Regulatory Group attorneys counsel companies before the FDA and its counterpart authorities abroad in all phases of the product development cycle, including strategic business planning, product development and testing, submissions, product marketing, regulatory compliance and enforcement and advertisement and promotion. Our attorneys have in-depth experience representing clients who are impacted by FDA regulations from concept through completion, including:

• Strategic Business Planning;
• Product Testing and Clinical Research;
• Application Submissions and Negotiation;
• Marketing FDA-Approved Products;
• Regulatory Compliance and Enforcement Matters;
• Regulation of Emerging Technologies at Home and Abroad;
• Domestic and International Chemical Control and Hazardous Waste Regulation;
• International Trade and Strategic Advice.

Clients we represent include FDA-regulated industries such as clinical research facilities, and manufacturers, processors, and distributors of:

• Pharmaceuticals and Biologic/Biotech Drugs — both prescription and over-the-counter (OTC);
• Food and Dietary Supplements;
• Medical Devices.

Further, our practice focuses on issues arising under the Hatch-Waxman Act, such as market exclusivity periods, patent listing and certification requirements, 505(b)(2) issues and bioequivalence standards. Our FDA regulatory lawyers work closely with our patent and antitrust lawyers to provide an integrated approach to important life cycle management issues.

Our commitment to high-quality service means we do more than address the immediate legal issues at hand—we create complete solutions to help clients meet their most crucial business goals.