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.

Risk Management & Medical Devices: 4 Common Problems to Avoid

Risk management has become a central focus for regulators over the past few years, a point underscored by this year’s draft revision to ISO 13485. Despite this, many device manufacturers don’t go far...Continue Reading

Medical Device Cybersecurity: New FDA Recommendations for Manufacturers

In January of 2016, FDA released new guidelines for postmarket cybersecurity measures in medical devices. These offer a number of best practices designed to assess and...Continue Reading

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