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REGULATORY MEANS BUSINESS
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ABOUT US
FDA Regulatory Counsel is a specialty law practice providing business-minded subject matter expertise to life science companies, lenders & investors, and law firms seeking to augment in house capabilities. We understand that today more than ever, legal knowledge is just the beginning - it is our judgment, perspective, relationships, and experience navigating regulatory systems that maximize our value to our clients.
ORIGINS
FDA Regulatory Counsel opened its first office in Washington, DC in 2013, founded by the former head of an AmLaw 100 Life Science Practice who saw the need for investors, lenders and regulated companies to directly access business-minded legal expertise on an as needed basis.
Historically, regulatory expertise has been concentrated in a shallow pool of experienced attorneys, most of whom cloister behind the walls of large law firms. Moreover, traditional compliance counsel often lacks the perspective to incorporate real-world client needs - not parroting regulations but developing strategies for handling legal issues in creative, business-centric ways. Our founding partner saw these gaps and set out to fill them.
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Over a decade later, FDARC continues to provide clients with direct, multi-faceted counsel incorporating legal expertise, business experience and long-standing DC relationships.
OUR PRINCIPAL
Ms. Gilmore has two decades of experience advising clients on regulatory compliance, commercial litigation, business matters and M&A transactions, ultimately rising to lead an AmLaw 100 FDA Practice Group. Prior to practicing law, Ms. Gilmore was a Management Consultant whose engagements spanned multiple consumer product industries.
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Ms. Gilmore is a national go-to FDA subject matter expert for private equity, commercial lenders, regulated businesses and top tier law firms needing in house FDA expertise. She is known for her pragmatic analysis of FDA policy and trends as they relate to business strategy and risk, advising clients in real-world terms.
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Additionally, Ms. Gilmore is recognized as a leading authority on 503A and 503B compounding pharmacy law, medical device pathways for emerging industries, health & wellness products, enforcement response, advertising & marketing on traditional and digital platforms and the regulation of innovative products. She is often called upon to educate legislators on cutting edge issues.
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Ms. Gilmore is a graduate of Duke University and Georgetown Law School. In addition to her JD, Ms. Gilmore also holds a Markets & Management Sciences degree from the Fuqua School of Business.
Melissa Gilmore JD
Founder & Managing Partner