Establishing the Pharmacovigilance System
Diapharm helps pharmaceutical companies reduce their workload and provides the following services:
- Assessment of existing pharmacovigilance activities (SOPs, literature monitoring, reporting, PSURs, safety alert plans, etc.) and risk minimization measures
- Development and documentation of the pharmacovigilance system (Pharmacovigilance System Master File; PSMF) for pharmaceutical companies, including annexes
- Preparation of Risk Management Plans (RMPs)
- Conducting internal audits
- Preparing for and supporting regulatory inspections
- Assuming statutory roles (Local QPPV, EU-QPPV)
An in-house PV system is not always the most cost-effective solution—comprehensive outsourcing can be more efficient. Diapharm offers a proven, BfArM-inspected PV system that you can utilize.
Summary-PSMF for Marketing Authorization
The summary description of the pharmacovigilance system (Summary of the Pharmacovigilance System Master File, or Summary-PSMF) and the risk management plan are essential components of marketing authorization applications. Diapharm is happy to support you with this as well.
