Audits

Under Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPV) requirements there is the need for companies to ensure that they implement a Quality Management System which is aligned with applicable internal and external standards and one key aspect of ensuring compliance with these requirements is the QA Audit function.


Reumat Consulting can assist companies in providing QA audit support by conducting a wide variety of audits in the GCP and GPV space which includes:

  • Vendors or External Service Providers

  • Company Affiliates 

  • Systems

  • Processes

  • Documentation (eg; Trial Master Files, Study Reports)

  • Investigator Sites

  • Business & Marketing Partners

Reumat Consulting can also help companies design audit programs by adopting a risk based approach to achieve an efficient and effective QA audit schedule.

 

If you would like to find out more about Reumat Consulting services, go to Contact

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