Cerulean’s mock FDA inspection and gap analysis for QSR, cGMP, Part 11, ICH or IMDRF compliance has been developed specifically for small to midsized businesses and single site divisions.
Plus one full year of free help preparing for any regulatory inspection or third-party audit.
And throughout, we’ll provide you clear-cut, practical answers on what’s required versus what’s a “nice-to-have.” Download a sample mock FDA audit schedule.
Most audits are done by one auditor, although additional auditors – former FDA employees and industry specialists – are brought in as required. The typical audit lasts between 2-3 days per site, with an additional 20-30 days required to draft the initial report and detailed recommendations, review the report with you and incorporate feedback, and then finalize the report.
Cerulean’s mock FDA audit clients receive one full year (12 months) of free help in the event of a regulatory inspection, a complete fee refund in the event we don’t meet our agreements with you, and much more. Learn about our industry-unique triple guarantee or see our preliminary cost range for a mock FDA audit.