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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Ranked #3
2015 & 2016
The FDA Group, LLC, Compliance Consulting, Westborough, MA


FDA Trends & Developments for the Medical Device Industry: 2016

Listen to our free recorded webinar.

FDA Trends & Developments for the Pharmaceutical Industry: 2016

Listen to our free recorded webinar.

How to Prepare for an FDA Inspection: 6 Quick Tips

Sooner or later, an FDA investigator will walk through your door, greet the receptionist and wait patiently for the leadership team to meet them in the lobby. The call goes out that FDA is in the...Continue Reading

Does My Modified Medical Device Require a New 510(k)?

 When medical devices undergo changes, it leaves sponsors asking a critical question: Does the change require a new 510(k) submission? Before trying to answer that question, it’s important to...Continue Reading

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