Auditing

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

Remediation

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.

Training

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

Regulatory

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:

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4 Years in a Row
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4 Years in a Row
The FDA Group, LLC, Compliance Consulting, Westborough, MA
4 Years in a Row
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ISO 13485:2016 & MDSAP: How to Prepare Your QMS Now

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