The FDA Group

The FDA Group is a life science staffing and consulting company that specialises in connecting FDA-regulated organisations with contracted subject matter experts in regulatory affairs and quality assurance. Founded in 2007, the company provides access to former FDA personnel and industry veterans who deliver strategic insight combined with hands-on execution across the entire product lifecycle, from clinical development through commercialisation. The FDA Group's proprietary matching process ensures clients receive the right expert for their specific needs, whether for high-level strategy, autonomous execution, or both, backed by internal project management oversight and a Total Quality Guarantee.

The FDA Group serves multiple sectors within the life science industry, including pharmaceutical development, biologic manufacturing, medical device companies, and clinical research organisations. The company specialises in regulatory submissions including IND applications, 510(k) strategy and submissions, and 505(b)(2) and ANDA submissions, alongside comprehensive audit and inspection services such as mock FDA inspections, quality system audits, GMP and GLP audits, and gap assessments. Additional core services encompass staff augmentation for quality and regulatory teams, remediation support for Form 483 and Warning Letter responses, quality system remediation, and CAPA implementation, complemented by QMS development and validation services.

The FDA Group operates globally with resources located across the contiguous United States and much of the world, maintaining its corporate headquarters in Boston, Massachusetts. The company distinguishes itself through exclusive life science focus, a 95 per cent first-time resource match success rate, and a 97 per cent client satisfaction rating. With thousands of life science firms relying on The FDA Group's network of former FDA officials and industry experts, the company has built its reputation on responsiveness, integrity, and measurable results, supported by dedicated account management and a commitment to quality that has guided resource selection since its founding.