Bridging Healthcare Through Expertise

Full EU Pharmacovigilance System Lease And Development

We provide comprehensive support in establishing and developing pharmacovigilance systems that meet the stringent requirements of the EU. Our team works closely with our clients to customize a system that aligns with their organizational needs and ensures compliance with all relevant regulations.

Building a Robust Pharmacovigilance Framework: Key Steps

QPPV

Selection of the EU Qualified Person for Pharmacovigilance

Database

Establishment and validation of a Safety Database

PSMF

Establishment of Pharmacovigilance System Master File

System

Professional consultations on Pharmacovigilance System implementation

Eudra

Registration of applicants within the EudraVigilance system

RMP

Preparation of the Risk Management Plan

LPPV

Formation of the Local PV system and selection of Local Persons for PV

SOPs

Integration of pharmacovigilance processes, SOPs, and quality system elements

Count on us as your trusted partner in navigating the dynamic terrain of drug safety and surveillance.