Pharmacovigilance

With regard to the constantly growing requirements in the field of pharmacovigilance, we offer the following services:

Provision of the German LPPV ("Stufenplanbeauftragter")

Provision of the external EU-QPPV

Preparation of risk management plans according to GVP V Rev. 2

Creation of PSURs / DSURs

GVP audits and due diligence of your pharmacovigilance system

Drug Safety in Clinical Studies (Phase I-III)

Compilation and review of the Safety Management Plans

Training of local PV partners

XEVMPD