Proactively identify and resolve compliance risks before regulators do. Our audit and mock inspection services connect you with former FDA investigators and seasoned industry auditors who know exactly where the agency looks, what triggers observations, and how to close gaps efficiently.
Whether you need a targeted GMP, GCP, GLP, or CSV audit—or a full-scale quality system or supplier assessment—we deliver clear, actionable findings and practical remediation guidance. Each engagement is designed to strengthen your inspection readiness, streamline compliance processes, and build lasting confidence across your operations.
From early-stage gap assessments to final mock inspections, we help you anticipate and address issues long before they reach the FDA’s radar. It’s the smarter, more strategic way to safeguard compliance and stay ahead of regulatory scrutiny.
All of our services are backed by a Total Quality Guarantee.
Get a true picture of compliance from professionals who’ve sat on both sides of the inspection table.
Pinpoint vulnerabilities across systems, suppliers, and processes before they become findings.
Our auditors help you interpret findings and implement improvements for lasting compliance.
We help you achieve and sustain a state of continuous inspection readiness across your operations.
Ensure your operations meet the highest regulatory standards across every GxP domain. Our former FDA investigators and industry auditors conduct comprehensive GMP, GLP, GCP, and related audits to assess compliance, data integrity, and system performance. From manufacturing and clinical research to digital systems and supplier oversight, we help you identify gaps, implement improvements, and maintain ongoing inspection readiness.
Prepare your team and facilities for real FDA inspections through realistic, high-fidelity simulations led by former FDA investigators. Our mock inspections and readiness reviews replicate authentic FDA techniques, helping you uncover vulnerabilities, strengthen response protocols, and build confidence across your organization. From PAIs and BIMO inspections to full facility readiness reviews, we help ensure your systems, records, and personnel are fully prepared when regulators arrive.
Address complex and emerging compliance areas with targeted audits led by experts who understand evolving regulatory expectations. From data integrity and pharmacovigilance to MDSAP, QMSR, and REMS, our specialists conduct in-depth evaluations that go beyond checklists to identify systemic risks and drive lasting improvement. These specialized audits help ensure readiness for FDA, EMA, Health Canada, and other global authorities while strengthening your overall quality and compliance posture.
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.
