End-to-end drug safety, from case to signal to QPPV.
Global Pharmacovigilance Services
Patient safety and regulatory compliance depend on a pharmacovigilance system that works at every stage — from individual case intake to signal detection, risk management and QPPV oversight. PharmExpert delivers end-to-end PV services and a flexible system model that scales from a single product to a global portfolio.
Case processing, literature monitoring, aggregate reporting, signal and risk management, SDEAs, QPPV services, medical information and post-marketing surveillance — combined into one coherent, inspection-ready safety system aligned to EU GVP and ICH.
Standards & Frameworks
- EU GVP Module VI
- ICH E2B(R3)
- ICH E2A/E2D
- MedDRA conventions
- ICH E2D
- EMA literature-monitoring expectations
- National requirements
- ICH E2C(R2)
- ICH E2F
- EU GVP Module VII
- US PADER requirements
- EU GVP Module IX
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