Pharmacovigilance
Pharmaco
vigilance
Adverse event intake, signal detection, and periodic reporting, aligned with EU GVP requirements. Continuous product safety monitoring with robust, auditable systems.
Our Capabilities
Safety that meets EU GVP standards
From case intake to signal detection, our pharmacovigilance capabilities protect your patients and keep your products compliant across every market.
Adverse Event Intake & Triage
24/7 intake of individual case safety reports (ICSRs) with medical triage, severity assessment, and timely regulatory submission in E2B format.
Signal Detection & Risk Assessment
Continuous signal detection and evaluation of the safety profile of products, from screening to confirmed signals and risk characterization.
Periodic Safety Reports
Preparation and submission of PSURs, DSURs, and RMPs aligned with EU GVP and local regulatory requirements for each market.
EU GVP Compliance & QPPV Support
Quality system design, SOP development, and Qualified Person for Pharmacovigilance (QPPV) support to ensure full EU GVP compliance.
Safety Database Management
Setup, maintenance, and validation of safety databases including MedDRA coding, causality assessment, and data quality controls.
Risk Management Plans
Development and lifecycle management of Risk Management Plans (RMPs) including risk minimization measures and effectiveness monitoring.
Ready to strengthen your safety monitoring?
Partner with us to manage adverse events, signals, and reporting with EU GVP rigor.