GxP Auditing

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

Remediation Support

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 improvement.

Regulatory Affairs

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
3 Years in a Row
3 Years in a Row
The FDA Group, LLC, Compliance Consulting, Westborough, MA
3 Years in a Row

Contributors to:


Harmonizing Disparate Quality Systems

Watch the free recorded webinar.

HHS Office of Human Research Protection Delays Implementation Deadline for Changes in Common Rule

The HHS Office of Human Research Protections is delaying by one year the implementation deadline for changes in the common rule, the regulations that govern human subjects research. The new effective...Continue Reading

503A vs. 503B: A Quick-Guide to Compounding Pharmacy Designations & Regulations

Since regulators have began put greater scrutiny on the compounding pharmacies following incidents linked to poor oversight by state boards of pharmacy, FDA has divided these pharmacies into two...Continue Reading

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