Product safety is essential throughout the entire lifecycle in the pharmaceutical market. We provide comprehensive pharmacovigilance services in full compliance with national and European legislation.
We implement rigorous processes for continuous safety monitoring, adverse reaction reporting, and the maintenance of long-term compliance.
•Implementation and maintenance of the local pharmacovigilance system
• Local Pharmacovigilance Responsible Person
• Collection, evaluation, and reporting of adverse reactions to competent authorities
• Monitoring of scientific literature
• Management of quality complaints with potential safety impact
• Development and updating of standard operating procedures (SOPs)
• Support in the preparation and submission of periodic safety reports (PSURs)
• Management of pharmacovigilance agreements with partners
• Internal audits and preparation for regulatory authority inspections
• Pharmacovigilance training for involved teams
