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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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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.
 

Does My Modified Medical Device Require a New 510(k)?

 When medical devices undergo changes, it leaves sponsors asking a critical question: Does the change require a new 510(k) submission? Before trying to answer that question, it’s important to...Continue Reading

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

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