Inspection/Due-Diligence Support

We have prepared for or hosted inspections by the regulatory authorities in 15+ countries including USA, European countries, Japan, India, China, South Africa, and Latin American countries. These include pre-approval inspections of sponsor and CRO, R&D and manufacturing facility, pre-clinical facility, Phase I & BA/BE center and investigator sites.

The inspection related services include training for inspection-readiness and hosting inspections, perform pre-inspection reviews (or a full mock-inspection), hosting of actual inspections and response to the regulatory authorities.

We can work as a quality and regulatory representative in your due-diligence team while in-licensing or out-licensing a product.