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


Qualifying Suppliers & Managing Quality in FDA-Regulated Industries

Join us for a free Webinar, Wednesday, December 7th, 2016
2:00pm to 3:00pm EST

NH-ISAC, MDISS & FDA Announce New Medical Device Cybersecurity Initiatives

In an effort to improve data sharing and cybersecurity in medical devices, three national organizations have signed a new Memorandum of Understanding (MOU) outlining new measures device...Continue Reading

Qualifying Suppliers & Managing Quality in FDA-Regulated Industries [Webinar]

In an age where manufacturing efficiency has become critically important for FDA-regulated manufacturers, outsourcing has become a global phenomenon. Third party suppliers and vendors can go a long...Continue Reading

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