Patient Safety First
Pharmacovigilance obligations begin before first-in-human studies and continue throughout a product's commercial life. Health authorities impose increasingly stringent requirements for adverse event collection and safety surveillance. Compliance failures carry serious consequences.
RegOps delivers pharmacovigilance support scaled to your organization's needs. Whether you require full-service safety operations or targeted support for specific activities, we provide the expertise, processes, and systems to maintain compliant pharmacovigilance. Our focus is always on patient safety—identifying and communicating safety signals that enable informed prescribing decisions.
Our Capabilities
Comprehensive safety services for clinical and marketed products.
End-to-end management of ICSRs including intake, coding, medical review, and QC. We process cases from clinical trials, post-marketing, and literature.
Timely submission of expedited and periodic reports to global health authorities. We manage ICSRs, SUSARs, and PSURs/PBRERs submission.
Systematic signal detection activities including disproportionality analysis and medical review. We establish processes that identify issues early.
Configuration and maintenance of safety databases (Argus, ArisG). We ensure your database supports compliant operations and analysis.
Authoring of PSURs, PBRERs, DSURs, and PADERs. We compile safety data, conduct benefit-risk assessments, and author compliant reports.
Assessment of PV systems against GVP requirements. We identify gaps, recommend remediation, and support inspection readiness activities.
The RegOps Advantage
We look beyond compliance to ensure true patient safety surveillance.
Safety Focus
We turn data into safety intelligence. Our medical expertise informs all case assessment and signal evaluation activities.
Global Compliance
We maintain current knowledge of PV requirements across major markets and ensure your operations meet standards everywhere.
Scalable Solutions
From single-product support to enterprise PV, we scale our services to match your portfolio complexity and safety volume.
Tech Agnostic
We work within your existing safety database environment or can provide our own, supporting optimization as your needs evolve.