About

FDARC is the nation's premier specialty regulatory firm providing on-demand expertise in corporate transactions and compliance for FDA-regulated products and compounding pharmacies. 

Mission

Origins

FDA Regulatory Counsel was founded in 2008 by the former chair of an AmLaw 100 FDA Life Science Practice Group with the progressive idea that every stakeholder in the life science industry should have access to high level FDA subject matter expertise.  Because the pool of experienced counsel is shallow, and the FDA's footprint broad, there is great efficiency in plugging in knowledge on demand.

Over a decade later, FDARC remains the nation's premier specialty regulatory law firm.

Our Principal

Ms. Gilmore has 25 years' experience practicing FDA regulatory law in Washington, ultimately rising to lead the Life Science Practice Group of an AmLaw 100 firm. She has advised clients in the medical device, drug, dietary supplement, cosmetics, and compounding pharmacy industries on all aspects of FDA compliance.

Ms. Gilmore is a national go-to subject matter expert for private equity, commercial lenders, regulated businesses and top-tier law firms without in-house regulatory counsel.

Additionally, Ms. Gilmore is recognized as a leading authority on 510(k) substantial equivalence, health & wellness, advertising/marketing, pharmacy law, and the regulation of innovative products. She has been called upon to educate legislators on cutting edge issues like the 503B Compounding Quality and Dietary Supplement Acts. 

Ms. Gilmore is a graduate of Duke University and Georgetown Law School. In addition to her JD, Ms. Gilmore also holds degrees in business and psychology. 

Melissa Gilmore JD

Managing Partner