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GxP Auditing

Expert Quality Assurance consulting and auditing services for GMP, GCP, GLP, and PV quality systems.

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Remediation

We will take you all the way through to compliance following a high quality compliance audit.

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Regulatory

Our regulatory affairs professionals have years of experience working with the FDA throughout the pharmaceutical, biotechnology, and medical device/diagnostic industries.

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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
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2015 & 2016
The FDA Group, LLC, Compliance Consulting, Westborough, MA

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Qualifying Suppliers & Managing Quality in FDA-Regulated Industries

Watch our free webinar recording.

The Data Integrity Triad: A Framework for FDA-Regulated Manufacturers

This article is an abbreviated introduction to Chinmoy Roy's "The Data Integrity Triad." Read the full article on LinkedIn here.The rise in Data Integrity warning letters are forcing companies...Continue Reading

6 Key Medical Device Provisions in the 21st Century Cures Act

The 21st Century Cures Act signed into law in December of 2016 attempts to build on FDA’s efforts to advance medical product innovation and improve patient access to treatments while continuing to...Continue Reading

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