The FDA Group is an organization that utilizes a proprietary talent selection process of former FDA & industry professionals, amplified by a corporate culture of responsiveness and execution. Headquartered in Westborough, Massachusetts, The FDA Group has 600+ specialists worldwide, 75+ of whom are former FDA.

Why is The FDA Group in business?

The FDA Group is in business to enhance the quality of people’s lives. Whether it is our clients, employees, contractors, vendors, communities, or the patients who receive the products we touch, our purpose lies in discovering meaningful ways to apply our experience, expertise, and passion for quality in everything we do.

How does The FDA Group do it?

We are able to do this through our proprietary talent selection process and deep-rooted corporate culture built upon 5 Core Values. These Core Values are the heartbeat of our organization and focus on the following concepts:

1. Respond with urgency.

2. Find a way to make it happen.

3. Communicate openly and honestly.

4. Be humbly confident.

5. Be easy to work with.

What does The FDA Group do?

The FDA Group is a global leader in GxP auditing, remediation support, staff augmentation, regulatory affairs, and expert witness services.

Core ValuesCore Values

Learn how our five Core Values can help you achieve extraordinary results.



Learn what makes us different and what sets us apart.


Success StoriesSuccess Stories

Read real-life success stories from clients just like you who we have helped in a variety of quality and regulatory compliance areas.

Case StudiesCase Studies

Learn how we’ve worked closely with clients like you to successfully identify and resolve a variety of quality and regulatory compliance issues.

Corporate Social ResponsibilityCorporate Social Responsibility

Learn how we help our staff promote social good by offering full compensation for time spent taking advantage of volunteer opportunities of their choice as well as the charitable organizations we support.