Inspection Readiness

Whilst most CROs will exit once you have completed your Phase 3 trials, ClinPro will continue to engage with you to help you get ready for your Pre-Approval Inspection. ClinPro Trials has over 20 years of experience in preparing for and hosting Pre-approval inspections. We can work with your internal team to ensure that all the required paperwork is ready, conduct Mock Inspections, provide inspection conduct training and back room and front room support to ensure that you have a successful pre-approval clinical inspection. We have successfully hosted pre-approval regulatory inspections with foreign agencies such as FDA, EMA, MHRA, PMDA (Japanese), SDA (Chinese), KFDA (Korean), TGA (Australian), ANVISA (Brazilian), CDSCO (Indian), Health Canada etc. We have extensive experience in the following regulations such as CFR 600’s, 820’s, 210, 211, 58, 50, 54, 314, 312, Part11, ICH EG Rev 02, 21CFR 1271 etc.