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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. 

  • The FDA regulates 1 in 4 consumer products sold in the U.S.

     

    Each of those products, and every company involved in bringing them to market, must comply with the Food, Drug & Cosmetic Act. Failure to do so results in enforcement actions: fines, recalls, remediation, enhanced surveillance and business interruption.

  • Industries

    Drugs & Biologics

    Medical Devices & Diagnostics

    Dietary Supplements

    Cosmetics & Aesthetics

    Health & Wellness

    Pharmacies

    Tobacco & Vape

    Food

    Veterinary

  • Scope

    Registration & Listing

    Product Approval & Clearance

    Manufacturing

    Labeling & Packaging

    Marketing, Advertising & Promotion

    Distribution

    Recordkeeping

    Adverse Event Reporting

    FDA Inspections & Recalls

  • There is no substitute for deep knowledge of FDA policy.

     

    Compliance requirements are not only complex, but also constantly evolving. As technology pushes innovation forward, FDA's oversight expands. Understanding the Agency's positions and priorities is critical to making informed business decisions.

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. 

1717 K St., NW

Suite 900

Washington, DC 20006

202.714.0856 

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FDARC

© 2021  by FDA Regulatory Counsel LLP

This site is not intended to be legal advice. Contacting the firm or reading the materials on the site does not create an attorney-client relationship. No confidential information should be sent over the internet. Past results do not predict future outcomes as each situation has to stand on its own.