Mock Regulatory Inspections
Our former Regulatory Authority inspectors are able to conduct realistic mock inspections to test the robustness of your systems and to prepare your staff for the real thing. We help companies through successful GCP and GVP inspections in many different countries.
Inspection preparation training
Inspection co-ordination and management
Optimising responses to inspection findings
Recent examples of our work:
Identified critical and major findings whilst preparing two sites for FDA inspections. Worked with sites and sponsor to put CAPA in place. During the FDA inspection one site received an FDA 483, whilst the other site had NAI. ADAMAS subsequently helped the site with their responses to the FDA 483, which were accepted by the FDA.
Conducted inspection readiness at investigator site and facilitated FDA inspection. The inspection outcome was NAI and the drug was subsequently approved by the FDA.
Pre-inspection training including planning and organisation, roles and responsibilities of staff and mock interviews
Many organisations are preparing themselves for GCP and Pharmacovigilance inspections. ADAMAS Consulting has the team, the skills and the experience to conduct Mock GCP and Pharmacovigilance Inspections according to your needs.
This may include, but is not limited to, the following:
- Gap Analysis
- Identifying and prioitising improvements
- Corrective Action Support
- Training – ‘Preparing for Inspection’
- Preparing a War Room
- Mock Inspection
- Hosting the Inspection
- Inspection interview training
- Preparing Sites for Inspection
The mock inspection was ‘perfect‘; a good experience that helped us prepare for the ‘real thing’. It was as real as possible.S.J.
If you've got any questions or queries about our services, careers, or training, please get in touch.
We have 500+ years combined experience, working around the globe there isn’t anything we’ve not encountered in our sector. We're very approachable and happy to help.