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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 FDA-regulated companies, private equity & commercial lenders, and law firms seeking FDA capabilities.
ORIGINS
FDA Regulatory Counsel opened its first office in Washington, DC in 2008, founded by the former head of an AmLaw 50 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 reside behind the walls of large law firms. Moreover, compliance counsel rarely has the experience to incorporate the business considerations necessary for implementation. Our founding partner saw these gaps and set out to fill them.
Fifteen years later, FDARC continues to provide clients with direct, multi-faceted counsel incorporating legal expertise, business experience and long-standing relationships with regulators.
OUR PRINCIPAL
Ms. Gilmore has 25 years' experience advising clients on regulatory compliance, commercial litigation, business matters and M&A transactions, ultimately rising to lead an AmLaw 50 FDA Practice Group. Prior to practicing law, Ms. Gilmore was a Management Consultant whose engagements spanned multiple consumer product industries.
Ms. Gilmore is a national go-to FDA subject matter expert for private equity, commercial lenders, regulated businesses and top tier law firms seeking in-house FDA counsel. She is known for her pragmatic analysis of FDA policy as it relates to business strategy and risk, advising clients in real-world terms.
Additionally, Ms. Gilmore is recognized as a leading authority on 510(k) substantial equivalence, health & wellness product regulation, advertising & marketing of FDA-regulated products, 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 a Markets & Management Sciences degree from the Fuqua School of Business.
Melissa Gilmore JD
Founder & Managing Partner