Regulatory inspections are some of the most intense moments a company faces. Even organizations with solid intent can struggle to produce the right records quickly, keep messages consistent, and show how daily practice matches written procedures. Without structured preparation, observations often stem from missing documentation, unclear roles, or small process gaps that were never stress tested. Audits and mock inspections give you the best chance to surface these weaknesses in advance, but they only add value when they realistically mirror how regulators work.
HIC designs and conducts audits and mock inspections that feel like the real thing. Former FDA investigators and experienced quality leaders simulate inspection conditions from document requests and walkthroughs to leadership and front line interviews. We test how your teams handle questions, how evidence is retrieved and presented, and how issues are escalated through defined quality pathways in real time. Findings are prioritized by regulatory risk, with clear recommendations and support for corrective actions. The outcome is a company that enters inspections prepared and coordinated, with a clearer view of where significant observations may arise and how to mitigate those risks.
Audits that make inspections more predictable
- Our audits are led by former FDA investigators who replicate real inspection patterns, document flows, and lines of questioning
- We review process execution, records, and quality oversight end to end so gaps are identified before regulators see them
- Teams receive coaching on inspection choreography, including room setup, document routing, and how staff respond during interviews
- We provide clear, prioritized findings and help drive follow up actions, so issues are closed and readiness is demonstrable before the next inspection
