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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The FDA Group, LLC, Compliance Consulting, Westborough, MA


Recovery from FDA Warning Letters & FDA 483

You are invited to join us for a free webinar.

6 Reasons to Get Expert Help When Handling Warning Letters & FDA 483

FDA Warning Letters and Form 483 Inspectional Observations, while not final determinations, are extremely important for companies to fully evaluate and resolve. What may seem like simple deficiencies...Continue Reading

A 5-Step Guide to FDA Warning Letter Recovery

FDA Warning Letters are official notices informing manufacturers and other companies they are in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act while providing them with an...Continue Reading

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