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