Soterius: Next-Gen Pharmacovigilance Services for a Safer Tomorrow Soterius delivers advanced pharmacovigilance services tailored for today’s dynamic life sciences industry. With a presence in 61 countries and experience across 250+ products, we offer global, tech-driven safety solutions that span the full product lifecycle — from clinical development to post-marketing surveillance. End-to-End Safety Expertise Our clinical safety services ensure seamless pharmacovigilance during trials. We work as an extension of your team, integrating CROs, sponsors, and tech providers into a centralized safety ecosystem. From case intake and safety data review to signal detection and development of core safety documents like DSURs and Investigator Brochures, we ensure regulatory readiness at every step. For post-marketed products, Soterius supports companies of all sizes — from global pharmaceutical leaders to growing biotech firms. We manage everything from AI-enabled intake and triage to risk management planning, periodic safety updates (PSURs, PADERs), and global submissions. Our safety professionals and local representatives ensure compliance across over 60 countries. Smart Systems, Streamlined Compliance We offer fully managed safety databases, SOP development, and end-to-end system setup. Our teams author and maintain Pharmacovigilance System Master Files (PSMF), ensuring your systems meet both global and region-specific requirements. We also lead in data reconciliation between safety and clinical systems, reducing lock timelines and improving data integrity. Our in-house platforms support real-time intake, reporting, and regulatory notifications. Global Literature & Signal Intelligence Soterius conducts global literature surveillance using databases like Embase and PubMed, with optimized strategies for signal detection. Our structured reporting offers clients insightful evaluations of emerging risks, supporting informed decision-making and compliance with global safety standards. Regulatory Support & Medical Monitoring Our expert team provides strategic responses to regulatory queries and inspections, manages QPPV and LRP services, and supports CCDS and RMP/REMS authoring. Our medical monitors bring therapeutic area expertise to proactively manage site-level safety and contribute to safety boards and data review meetings.
Why Soterius? With 30–50% typical cost savings and 99.x% quality scores, Soterius combines technology, expertise, and global reach to offer truly next-generation pharmacovigilance services. Whether it’s a drug, device, biologic, or nutraceutical — we help you safeguard patients and stay compliant worldwide.
