Melissa Gilmore

Founding Partner @Fda Regulatory Counsel Llp

Washington, DC, US

Business-minded compliance counsel and strategic advisory for life science consumer product companies, law firms, private equity and commercial lenders/investors in FDA-regulated spacesDeep knowledge of law, regulation and policy surrounding 503A/B compounding pharmacies, medical devices and diagnostics (including LDTs), drugs, telehealth, digital health and medtech, dietary supplements, cosmetics and aesthetics, tobacco/nicotine, food and beverage, cannabis and other regulated productsLegal advisory on complex matters throughout product life cycle, including product development, risk assessment and solutions, pre-market submissions, product claims, packaging, labeling, advertising, promotion, FTC, AKS, Sunshine Act, CPOM, post-market compliance, cGMP/QSR manufacturing standards, imports, adverse event reporting, inspections, 483s, recalls/market withdrawals, warning letters, consent decrees and remediation measures Government affairs and advocacy, Agency communications, and regulatory analysis surrounding innovative products and technologies, evolving regulatory paradigms, statutory interpretation, Guidance and enforcement policiesDue diligence, risk mitigation, deal documentation, and post-event matters for M&A and other corporate transactions involving FDA-regulated companiesSubject matter expertise in support of product liability, regulatory litigation and business contracting

Harvard University

Master in Liberal Arts, Psychology

Duke University - The Fuqua School of Business

Leadership & Entrepreneurship

Georgetown University Law Center

Juris Doctor (J.D.), magna cum laude

Duke University

Bachelor of Arts (A.B.), cum laude