Locke Lord’s FDA Regulatory Practice offers a unique combination of broad-based legislative and regulatory experience, knowledge of the industries we serve and scientific capabilities. From day-to-day counseling to major institutional crises, we understand our clients’ strategic commercial priorities and their product portfolios. This allows us to offer comprehensive counseling and sophisticated and effective advocacy.
The Locke Lord team has decades of collective experience in all facets of pharmaceutical, biologic, medical device, food, cosmetics and dietary supplement regulation. We represent our clients in all phases of the product life cycle, from discovery through clinical investigation, premarket review and post-market regulation, including clinical trial compliance, licensing agreements, product clearance, approval and registration, product and ingredient notifications and recalls, inspections, audits, Warning Letters and Citizen Petitions, civil and criminal investigations and litigation, as well as congressional oversight.
We provide strategic management of complex regulatory and legislative issues, both to establish and maintain compliance with existing laws and regulations, as well as to help our clients build strong reputations and lasting relationships with key decision-makers. We work closely with clients to enhance their understanding of agency decisions and policies, while helping them to anticipate and benefit from regulatory and public policy changes. Our practice has built coalitions to advocate on behalf of collective interests and worked closely with trade associations and specialty groups to enact legislation or reform regulations.
Our team members bring significant global experience from within the FDA, Congress and private industry. Our lawyers have worked in senior-level positions in Cabinet departments, on Capitol Hill, in regulatory agencies and in industry trade associations. Our practice is fully integrated with our other Firm practice areas, such as corporate, IP advertising, product liability, litigation, government relations and other disciplines. Our objective is to bring the right solutions for the issues and challenges that confront our clients.