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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 head 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 to plugging in knowledge on demand.

Over a decade later, FDARC remains the nation's premier regulatory boutique.

Vision

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Melissa Gilmore JD

Managing Partner

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