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We can structure and organize your quality management
You can call on the following services to help establish and develop your quality assurance system:
- Drafting of a quality assurance manual, incl. all the SOPs needed for your company
- Drafting of individual SOPs for special functions
- Training of staff
- Implementation of self-inspections according to the law (PharmBetrV) incl. Inspection report and plan of action
- Follow-up phase after self-inspection
- Trial audits
- Pre-trial audits (trial protocol, CRF, etc.)
- In-house audits (process analysis)
- On-site audits (external suppliers, study centres)
- Laboratory audits
- Audit of final reports, Expert Reports (medical/scientific and pharmacotoxicological)
- System audits (e.g. CRO, study centre, laboratory, sponsor, drug safety)
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Quality Assurance
