Melissa Gilmore

Melissa Gilmore represents life sciences and consumer product companies and investors on high-stakes regulatory and transactional matters in FDA-regulated industries.

She supports clients across the full product lifecycle, helping them bring products to market, manage compliance exposure, and execute strategic transactions in sectors including pharmaceuticals, medical devices and diagnostics, digital health, dietary supplements, cosmetics and food and beverage.

Melissa structures regulatory strategies for product development and commercialization, addressing pre-market pathways, labeling, advertising, promotion and compliance under FDA and FTC requirements. She counsels on fraud and abuse laws, including the Anti-Kickback Statute and Sunshine Act, and guides clients through risk enforcement matters, including inspections, Form 483 observations, warning letters, recalls and remediation efforts. Her work extends to advising on manufacturing standards, imports, adverse event reporting, and post-market obligations, delivering practical solutions that align regulatory requirements with business goals.

Melissa also supports private equity sponsors, lenders, and strategic buyers in transactions involving FDA-regulated companies, leading regulatory due diligence, identifying regulatory risks and advising on post-closing compliance. She works closely with clients on government affairs, agency engagement and regulatory strategy for emerging products and evolving policy frameworks, helping them anticipate enforcement trends and position their businesses for growth.

Melissa brings two decades of experience spanning private practice, leadership of an AmLaw 100 FDA practice and prior work as a management consultant. She regularly handles matters involving medical devices, OTC and prescription drugs, 503A and 503B compounding pharmacies, telehealth, nicotine products, dietary supplements and innovative health and wellness products, and engages with policymakers on emerging issues shaping the industry and serves as a single point of contact with FDA on behalf of clients.