GxP Auditing

Expert Quality Assurance consulting and auditing services for GMP, GCP, GLP, and PV quality systems.



We will take you all the way through to compliance following a high quality compliance audit.



Our regulatory affairs professionals have years of experience working with the FDA throughout the pharmaceutical, biotechnology, and medical device/diagnostic industries.


Expert Witness

Choose from our selection of former FDA & industry experts to find qualified expert witnesses for your case.

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The FDA Group, LLC, Compliance Consulting, Westborough, MA


Recovery from FDA Warning Letters & FDA 483

Listen to a recording of our recent webinar.

Press Release: The FDA Group Hires Industry Expert Brie Stoianoff as Director of Quality & Service Assurance

WESTBOROUGH, MA, Aug. 9, 2016 -- Brie Stoianoff has joined The FDA Group in a newly created role as Director of Quality & Service Assurance.  Ms. Stoianoff comes to the company with more...Continue Reading

Adopting FDA’s Benefit-Risk Approach to Medical Device Compliance & Enforcement Decisions

In June, FDA released a draft guidance intended to clarify the benefit and risk factors they will consider for medical device compliance and enforcement actions that could impact device availability....Continue Reading

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