Cross-functional review of Quality, Clinical, Regulatory, IP, Market assessment of Pharma and Biotech start-ups
Mock Inspections should be prepared for an anticipated upcoming regulatory inspection by undergoing the rigor and scrutiny of a "live fire" experience and prepare to pass a real life Due Diligence from investments companies.
These Mock Inspections tests and evaluate the readiness of the company personnel and systems to deal with the various aspects of regulatory inspections, or the quality of aquired data, documentation systems.
Mock Inspections should be completed at least 2-3 months before an anticipated regulatory inspection to allow ample time to address and correct any identified gaps in the Quality Systems or personnel behavior. At least 2-3 days should be scheduled for Mock Inspections.