Pharmacovigilance System Set-Up
Developing a pharmacovigilance system and its quality system can tie up capacities and become a challenge. At Insuvia we aim to help pharmaceutical companies overcome this faster, easier, and cost-effectively. We work around the deadlines, no matter how tight. We make sure that you have the PSMF, EudraVigilance, and QPPV details for your Marketing Authorization Application on time.
Our pharmacovigilance processes are specifically adapted to the needs of small and mid-sized pharmaceutical companies. We provide them with a cost-effective full-service safety department as an outsourced solution. We can establish a compliant Pharmacovigilance System, create and maintain the Pharmacovigilance System Master File, provide a full QPPV Office or any part of it, and help you fulfil all pharmacovigilance obligations in the EU & UK, CIS, or MENA.
Set-Up of Pharmacovigilance System Master File (PSMF)
Appointment of the EU Qualified Person for Pharmacovigilance (EU QPPV)
Applicants’ registration in the EudraVigilance system
Implementation of a pharmacovigilance processes, SOPs and quality system aspects
Set-up and validation of a Safety Database
Risk Management Plan development
Consultations on Pharmacovigilance System implementation