GxP Auditing

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

Remediation

We will implement the necessary measures to safeguard your reputation for quality both now and in the future.

Quality System Resourcing

Work with experienced quality professionals to evaluate, correct, and support continuous quality system improvment.

Expert Witness

Choose from our selection of former FDA & industry experts to find qualified expert witnesses for your case.

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2016 & 2017
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2015 & 2016
The FDA Group, LLC, Compliance Consulting, Westborough, MA

Contributors to:

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Preparing for the Medical Device Single Audit Program (MDSAP)

Watch our free recorded webinar.

4 Ways ICH E6 (R2) 2016 Impacts Good Clinical Practice (GCP)

The release of the ICH Guideline for Good Clinical Practice (E6 R2) in November of 2016 has, for the first time in over a decade, put new guidelines and regulations in front of clinical trial...Continue Reading

Audit Trail Requirements in Electronic GxP Systems: A Quick Guide

For drug and device manufacturers in the United States, electronic records created through computerized systems must be maintained in accordance with FDA’s 21 CFR Part 11 and EudraLex Volume 4 Annex...Continue Reading

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