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...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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