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)

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