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, 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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Laboratory Developed Tests: Issues and Anticipated Regulations


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9 Top FDA 483 and Warning Letter Problems for Device Companies in 2015

While an inspection may seem like a distant concern, class II and class III manufacturers are technically subject to one at least every two years. FDA’s regulations for quality systems––FDA 21 CFR...Continue Reading

Press Release: The FDA Group Ranks #3 on Boston Business Journal's "FAST50" 2016

The FDA Group Ranks #3 on Boston Business Journal's "FAST50" List with 892.78% growth from 2012 to 2015.   WESTBOROUGH, MA, May 18, 2016 -- The Boston Business Journal recently ranked The...Continue Reading

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