Pharmacovigilance Services
We provide comprehensive pharmacovigilance services covering all the regulatory needs of pharmaceutical companies in this frame.
Our services include:
- Pharmacovigilance system set-up including SOP writing and preparation/maintenance of Pharmacovigilance System Master File (PSMF),
- Collection, assessment, reporting and follow-up of adverse reactions,
- Local and global literature screening and review,
- Preparation and regulatory submission of Periodic Benefit Risk Evaluation Reports (PBRER),
- Risk management activities (preparation and submission of risk management plan and materials related with risk minimization activities),
- Signal management,
- Monitoring and submission of safety alerts,
- Safety Data Exchange Agreements (SDEA) preparation and maintenance,
- In-house Pharmacovigilance trainings,
- Inspection readiness,
- Implementation of Corrective Actions / Preventive Actions (CAPAs)
