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 more than 445 specialists (65 of whom are former FDA Investigators) across 42 states.

Why is The FDA Group in business?

We are in business to provide our clients with a world-class service experience that assures them and their stakeholders that their products are brought to market expeditiously and are of the highest quality through a quality system that is compliant and efficient.

How does The FDA Group do it?

Through our proprietary talent selection process and deep-rooted corporate culture built upon 25 fundamentals. These fundamentals are the heartbeat of our organization and focus on four primary concepts:

  1. Core Values: Ten values that form the cornerstone of our success.
  2. Focus on Service: These client-centered habits ensure you receive an extraordinary service experience.
  3. The Collaborative Way: These practices transform our network of professionals into a powerful extension of your quality team.
  4. Personal Effectiveness: These behaviors help us achieve greater personal, and by extension, organizational success.

What does The FDA Group do?

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


Learn how our 25 fundamentals can help you achieve extraordinary results.
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Success 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 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 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.