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Our team lead liaises with all relevant project stakeholders regarding quality issues and study status and helps you with all aspects of the audit process. We support you throughout any of the following.
- Quality Manual
- Audit
- Deviation
- CAPA
Following the audit, we identify issues for the responsible parties to resolve at the project level.
If we identify broader, systematic problems, we help you operationalize corrective & preventive action plans to resolve these issues.
Additional services include:
Regulatory strategy
Training on ICH-GCP, GMP etc.
Quality metrics for management reporting
Investigator meeting support, e.g. presentations on GCP,
Common audit findings and handling regulatory inspections at sites
Regulatory inspection support, e.g. hosting inspections or preparing investigator sites for inspections
Standalone auditing services
