End-to-end pharmacovigilance services — from adverse event processing to regulatory submissions. Ensure patient safety and maintain regulatory compliance throughout your product lifecycle.
Collection, triage, and medical coding of Individual Case Safety Reports (ICSRs) using MedDRA terminology. Narrative writing and causality assessment.
Quantitative and qualitative signal detection using WHO-UMC, EBGM, and PRR methods. Case clustering and signal validation workflows.
Preparation of PSURs, PBRERs, PADERs, and DSURs in accordance with ICH E2C(R2) and regional authority requirements.
Development and maintenance of RMPs, REMSs, and minimization measures. Effectiveness assessment and ongoing benefit-risk evaluation.
E2B(R3) XML submissions to EudraVigilance, FDA FAERS, CDSCO, and MedDRA-coded submissions to global health authorities.
Systematic screening of published and unpublished medical literature for safety-relevant information using automated and manual review.
Our PV team is trained in all major regulatory frameworks and maintains ongoing continuing education to track evolving guidance.
Tell us about your product stage and safety monitoring needs.