The FDA Group

The FDA Group is a life science resourcing firm headquartered in Boston, Massachusetts. It provides staff augmentation, consulting projects, audits and mock inspections, remediation and regulatory submission support, and also offers contingent and direct hire candidate search and placement. Its staffing work covers quality, regulatory affairs and clinical operations roles.

The company serves pharmaceutical, biologic and medical device organisations, including contract development and manufacturing organisations and contract research organisations, and says it focuses exclusively on FDA-regulated industries. It reports over 3,750 resources worldwide, over 325 of them former FDA employees, located in 48 states and 75 countries. Contracted resources can work on site or off site as an extension of the client's team.

Nicholas Capman, president and chief executive officer, has led the company since December 2006. The company has also introduced an AI tool, the Audit Intelligence Compliance Assistant, for compliance auditing in pharma and biologics.