Comprehensive Drug Safety and Pharmacovigilance (PV) services. Protecting patient health through rigorous case processing, signal detection, and global regulatory compliance.
Safety Database Setup
Case Triage & Narrative
Disproportionality Analysis
PSUR, PBRER, DSUR
FDA E2B(R3), EMA Gateway
Complete safety surveillance across clinical and post-marketing phases.
End-to-end Individual Case Safety Report (ICSR) management: intake, triage, MedDRA coding, medical assessment, and narrative writing.
Continuous safety signal evaluation using statistical algorithms, qualitative analysis, and Risk Management Plan (RMP) authoring.
Authoring and compilation of Periodic Safety Update Reports (PSUR), PBRER, Development Safety Update Reports (DSUR), and PADD reports.
Configuration, migration, and 21 CFR Part 11 validation of industry-standard safety databases (Oracle Argus Safety, ArisGlobal LifeSphere).
Ensuring compliance with FDA 15-day reporting, EMA EudraVigilance gateway integration, MHRA submissions, and mock GVP audit inspections.
Our drug safety physicians and PV specialists manage global safety surveillance for biopharmaceutical innovators. We combine regulatory expertise with automation to guarantee 100% compliance and patient protection.