PHARMACOVIGILANCE SYSTEM AUDITS

Conducting periodic pharmacovigilance system audits is a regulatory requirement for MAHs.

Audits help assess the current state of the PV system and its compliance with regulatory requirements, as well as identify areas for improvement.

Audits may be performed by internal auditors or qualified external experts.

We offer PV system audits for MAHs. Furthermore, we provide consulting support in developing and implementing corrective and preventive action plans (CAPAs) based on audit results.