End-to-End Clinical Safety Services
Our clinical safety solutions are designed to manage risk proactively while maintaining strict regulatory compliance. We offer:
- Clinical and Post-Marketing Case Management – Accurate case intake, processing, medical review, and narrative writing aligned with global standards.
- Serious Adverse Event (SAE) Management – Timely assessment of seriousness, causality, and expectedness, with expedited reporting support.
- Signal Detection & Risk Management – Ongoing safety surveillance, signal evaluation, and risk mitigation strategies.
- Aggregate Report Writing – Preparation of PSURs, PBRERs, DSURs, RMPs, and other regulatory safety documents.
- Global Regulatory Oversight – Support from experienced QPPVs and Local Safety Managers across 60+ countries.
With 24/7 availability and inspection-ready quality systems, Soterius ensures seamless compliance with global pharmacovigilance regulations.
