Pharmacovigilance Audits

Pharmaceutical companies are legally obliged to ensure internal compliance but also compliance of affiliates, distribution partner and 3rd parties through audits.

  • During an audit, we look at each aspect of the PV process, from case processing to safety reports.
  • As part of the audit, we assess not only the role of the responsible persons within the organization but also quality management systems, the safety database, staff training and back-up procedures. 
  • Processes are identified, specified and assessed - including related GCP, GDP and GMP issues.
  • Our audits are QM-based with processes and templates very similar to the approach taken by the European competent authorities and international ISO audit standards. Our rating of audit observations follows the standard classification used by the EMA and other European Authorities.
  • Since different partner and affiliates often fulfil the same tasks regarding pharmacovigilance we offer strategic and elaborated PV audits adopted to your situation and needs. 

If you are interested in PV audits or support of an internal audit please feel free to contact us. 

We are looking forward to your audit enquiry.

Processes - SOPs

PV processes should comply with regulatory requirements through corresponding conception, design and implementation >>

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