Expert Quality Assurance consulting and auditing services for GMP, GCP, GLP, Vendor/Supplier, PV, Data Integrity, and MDSAP.


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

Staff Augmentation

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


Master the complexities of drug, device, and biologic compliance through customized training programs led by former FDA officials and industry experts.


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

Expert Witness

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

Awards and Accreditations:

fast 50
5 Years in a Row
5 Years in a Row
The FDA Group, LLC, Compliance Consulting, Westborough, MA
5 Years in a Row

Contributors to:

Proven Process:


The OTC Drug Manufacturer's Guide to CGMP Compliance & Quality Management

A free white paper.

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