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On-Demand FDA Expertise

FDA Regulatory Counsel is the nation's premier specialty FDA law firm. Founded by the former head of an AmLaw 100 Life Science Practice Group, we advise regulated companies on compliance issues and perform FDA due diligence for top tier middle market private equity, commercial lending and corporate deal teams.

Seamlessly expand your capabilities by adding partner level regulatory expertise on an as-needed basis. 

Subject matter expertise in FDA law has traditionally been concentrated in a small field of experienced attorneys, most of whom reside behind the walls of large law firms. Our founding partner saw the need for easier access to knowledge - directly, on a project basis and without prohibitive overhead. Over a decade later, FDARC remains the nation's premier regulatory boutique advising deal teams, regulated businesses and law firms without in-house FDA expertise.

FDA Due Diligence

FDA Regulatory Counsel combines go-to national subject matter expertise with the transactional experience of hundreds of middle market deals with FDA-regulated entities. Our attorneys perform business-minded diligence for M&A, corporate finance, VC and PE, drawing on our familiarity with current market and a deep well of industry history. We are experienced on buy and sell side transactions, and have considerable experience working on initial divestitures with original founders.