While we welcome applications from all FDA backgrounds, we particularly value experience in several key specialty areas.
FDA investigators who understand the nuances of facility inspections, can identify compliance issues, and know what constitutes a properly remediated observation.
Professionals with experience in Form 483s, Warning Letters, Consent Decrees, import alerts, and other enforcement actions who can guide companies through remediation efforts.
Former reviewers who understand the pathways to market for drugs, biologics, and medical devices, from IND/IDE submissions through NDA/BLA/PMA approvals.
Directors, branch chiefs, and other leaders who can provide strategic insight on agency thinking and regulatory trends.
Our former FDA consultants engage in a variety of meaningful projects, including, but certainly not limited to the following areas. Click or tap to expand each section.
Leading remediation efforts following FDA inspections, Form 483 observations, Warning Letters, and other enforcement actions.
Developing and implementing quality systems that meet regulatory requirements.
Conducting gap analyses to identify compliance vulnerabilities before regulatory scrutiny.
Conducting audits and mock FDA inspections to prepare companies for the real thing.
Training personnel on inspection management and interview techniques.
Developing inspection readiness programs.
Providing strategic guidance on regulatory submission pathways.
Reviewing regulatory submissions before agency filing.
Helping address deficiency letters and information requests.
Creating robust compliance monitoring programs.
Implementing data integrity controls and governance systems.
Designing effective CAPA systems and complaint handling processes.
Our firm regularly attracts former FDA staffers looking to enter the consulting space. Joining The FDA Group as a consultant offers several advantages.
Meaningful work.
Continue the mission of protecting public health by ensuring the safety, efficacy, and security of drugs, biologics, and medical devices.
Professional flexibility.
Engage in consulting opportunities that match your expertise and desired work schedule. Whether you prefer short-term projects, long-term engagements, or part-time consulting, we work with you to find the right fit.
Your specialized FDA experience is highly valued in the private sector, and our compensation reflects that reality. Many of our consultants find they can maintain or improve their financial position while gaining more flexibility.
Apply your regulatory knowledge while developing new skills in consulting and private sector collaboration. Many consultants discover that their FDA experience takes on new dimensions when applied to industry challenges.
Work alongside fellow former FDA professionals who understand your background and value your perspective. Our network includes hundreds of former FDA colleagues who share your commitment to public health and regulatory excellence.
