
GCP Mock inspections Europe
Introduction
Danish R&D Pharmaceutical Company
Our client is a pharmaceutical company committed to ensuring compliance with global regulatory standards, particularly FDA requirements for clinical trials
Apotech auditors
Our Auditors have 20+ years' experience, all based locally with extensive experience in FDA inspections and GCP compliance. Collectively conducted over 50 regulatory inspections in the past 5 years.
Types of Audits
- GCP audits
- Investigator sites
Standards
- FDA regulations
- ICH GCP guidelines
Audit Locations
- Poland
- Germany (*2)
- Spain

Scope of work

Project manage and conduct FDA mock inspections at 4 investigator sites across 3 European countries.

All audits are within GVP

Preparation of audit tools, including worksheets, checklists and training materials

Conduct mock inspections: Initial meeting, interviews with key site personnel, documentation review and exit meeting.

Apotech delivery team consisted of a Senior Project Manager, Business Manager and a team of 6 Auditors

Issue detailed audit reports and provide corrective action support

Key numbers

Team
3 Lead GCP Auditors

Location
Europe

Length
2 months

Type
Workpackages