Our Principal

OUR PRINCIPAL

Melissa Gilmore, Esq. has 20 years’ experience practicing FDA regulatory law in Washington, DC, ultimately rising to lead the FDA Practice Group of an AmLaw 100 firm. She has advised and consulted with device, drug, dietary supplement, pharmacy, and cosmetics clients of all sizes and stages and in all aspects of FDA compliance. Ms. Gilmore now brings her expertise directly to regulated companies and to law firms where she inserts FDA regulatory counsel to support their own clients’ needs.

NATIONAL GO-TO SUBJECT MATTER EXPERT

In the course of her representation, Melissa Gilmore has also become a national go-to subject matter expert for FDA due diligence in corporate transactions, applying her accumulated knowledge to assess and apportion risk in FDA due diligence. Many of the nation’s most prolific corporate groups rely on Ms. Gilmore as their client service FDA regulatory lawyer.  Ms. Gilmore brings this same acumen to FDA-related litigation client teams in legal or consulting capacities. She is also recognized as a leading authority on the 503B Compounding Quality Act, and was called upon to educate legislators on Capitol Hill during its drafting.

ACTIVE COMMUNITY LEADER

Melissa Gilmore is a cum laude graduate of Duke University and Georgetown Law School. She is an active member of the life sciences community and speaks around the country on topics of FDA transactional law, FDA regulatory law, and pharmacy law.