Our Experts has a vast experience in hosting, co-ordination and management of  inspections by the regulatory authorities of USFDA, EMA, MHRA, PMD, ANVISA, DCG(I), OECD GLP, WHO, ISO 17025, ISO 15189,  These include pre-approval inspections of Sponsor, CRO, Manufacturing facility, Phase I – IV / RWE and BA/BE center.

We provide support throughout the inspection process including preparation, hosting, response/follow-up. This can include conducting mock inspections and interview training.

Our experts offer consulting services to support clients with preparation for any health authority inspections globally, inclusive of:

⦁ Mock inspections to ensure inspection readiness

⦁ Manage the pre-inspection requests from inspectors

⦁ Organize the agenda for the inspection

⦁ Assist in preparation of material to be presented during the inspection

⦁ Assist in addressing the queries from inspectors during the inspection

⦁ Responses to the findings with robust investigation and strong action plan to mitigate the identified issue.