GCP Mock inspections – Europe
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 GCP
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
Apotech is capable of assembling a team of lead auditors to implement a global FDA mock inspection program. Their expertise ensured us as a sponsor taht our investigator sites were well-prepared, significantly increasing the likelihood of FDA approval.
Key numbers
Team
3 Lead GCP Auditors
Location
Europe
Length
2 months
Type
Workpackages
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