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.
Selection of the EU Qualified Person for Pharmacovigilance
Establishment and validation of a Safety Database
Establishment of Pharmacovigilance System Master File
Professional consultations on Pharmacovigilance System implementation
Registration of applicants within the EudraVigilance system
Preparation of the Risk Management Plan
Formation of the Local PV system and selection of Local Persons for PV
Integration of pharmacovigilance processes, SOPs, and quality system elements