Our end-to-end pharmacovigilance solutions are structured to maintain robust risk–benefit profiles and ensure timely regulatory submissions. We offer:
- ICSR Case Intake & Processing – Accurate data capture, medical review, coding, and submission of post-marketing adverse events.
- Expedited & Periodic Reporting – Timely submission of expedited reports in accordance with global regulatory timelines.
- Signal Detection & Risk Evaluation – Continuous safety surveillance, signal management, and risk assessment activities.
- Aggregate Report Writing – Preparation of PSURs, PBRERs, and other required safety documentation.
- Global Regulatory Support – Oversight from experienced QPPVs and Local Safety Managers across 60+ countries.
With 24/7 operational support and inspection-ready quality systems, Soterius ensures seamless compliance with international pharmacovigilance standards.
