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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

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FDA Issues Final Guidance Covering CGMP Requirements for Combination Products

The U.S. Food and Drug Administration (FDA) issued its final guidance covering good manufacturing practice (CGMP) requirements for combination products. We've summarized the key takeaways from the...Continue Reading

Inadequate CAPA Tops List of Compliance Problems for Medical Device Companies in 2016

Looking back on FDA’s inspectional observations issued throughout 2016, inadequate CAPA procedures topped the list at 344, followed by poor complaint handling and lack of written MDR procedures....Continue Reading

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