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

Listen to a recording of our recent webinar.

Adopting FDA’s Benefit-Risk Approach to Medical Device Compliance & Enforcement Decisions

In June, FDA released a draft guidance intended to clarify the benefit and risk factors they will consider for medical device compliance and enforcement actions that could impact device availability....Continue Reading

6 Supplier Quality Mistakes FDA-Regulated Companies Should Avoid

An analysis of Warning Letters and other FDA communications over the past five years reveals a few key mistakes pharmaceutical, medical device and other regulated companies are making time and time...Continue Reading

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