Hosting an inspection by the regulatory authorities can be a daunting experience for many clinical research organisations, especially if it is the first time or if personnel only have limited inspection experience.
Inspection Support and Facilitation
Closed Loop Quality Ltd. has extensive experience over many years in successfully preparing, coaching, and facilitating inspection activities within various clinical research and pharmaceutical organisations, within both the GCP and healthcare arenas. With experience in approximately 12 different inspection activities (Including for example the FDA, MHRA, EMEA and PMCPA), the aim is always to ensure an organisation can bring all the required resources to bear for a successful inspection result, whilst ensuring that the organisation can continue to operate its day-to-day activities.
Mock Inspection Performance
Closed Loop Quality also has experience in performing mock inspections of organisations to assess inspection readiness, and is able to tailor the inspection approach for different scenarios as required depending on the regulatory authority in scope. To date, this has included mock inspections based on the following regulatory/industry authorities:
- MHRA
- PMCPA