When compliance breaks down, you need more than a quick fix—you need a partner who understands how to rebuild trust with regulators. Our remediation specialists move fast to contain risk, correct deficiencies, and implement lasting improvements that strengthen your entire quality system.
Whether responding to FDA findings, addressing data integrity issues, or rebuilding processes from the ground up, we turn reactive remediation into proactive transformation. The result is a stronger, more resilient organization ready to sustain compliance and operational excellence long after the crisis has passed.
All of our services are backed by a Total Quality Guarantee.
Deploy seasoned remediation teams who know exactly how to respond when regulatory pressure is high.
Go beyond quick fixes with structural, sustainable improvements that align with current FDA expectations.
Implement systems that turn findings into continuous improvement opportunities.
Our team includes former FDA investigators and industry experts who know how to get you—and keep you—compliant.
Rebuild quality systems to meet FDA expectations and sustain compliance over time. Our team pinpoints systemic root causes, executes effective CAPAs, and redesigns processes to restore regulatory confidence while improving day-to-day performance.
Respond decisively when the FDA takes action. Our regulatory experts—many of them former FDA officials—help you craft effective responses that demonstrate control, address root causes, and prevent further escalation. From 483s and Warning Letters to consent decrees and import holds, we guide you through every step of remediation, communication, and documentation to restore compliance and protect your business continuity.
Learn how The FDA Group deployed its staff augmentation model to support a multinational pharmaceutical company's QMS remediation efforts. This project principally included deviation and CAPA backlog activities, significant corrective and preventive remediation throughout the quality system, and extended support to assist in staff onboarding, training, and maintaining the continuity of improvements made across the QMS. The FDA Group accomplished its goal of eliminating all backlogs on time and under budget.
Learn how The FDA Group partnered with a large clinical service company to manage its QMS remediation efforts and fulfill long-term staffing assignments for two vital roles in the management of the company’s quality and pharmacovigilance functions. This case study demonstrates the value of our convenient, cost-effective staff augmentation model as a means of circumventing the administrative costs and burdens of traditional hiring.
