We structure and organize your quality management...
You can take advantage of the following services to set up and expand your quality assurance system:
- Creation of a quality assurance manual including all SOPs necessary for your company.
- Creation of SOPs for special tasks
- Training of employees
- Execution of self-inspections according to AMWHV incl. inspection report and action plan including follow-up phase after self-inspection
- audits of suppliers and study facilities
- on-site audits (external suppliers, test facilities)
- pre-trial audits (test plan, CRF, etc.)
- laboratory audits
- audit of final reports, expert reports (Med.-Wiss. and Pharm.-Tox.)
- System audits (e.g. CRO, trial site, laboratory, sponsor, drug safety)
