Pharmacovigilance
An EU pharmacovigilance system built to EMA Good Pharmacovigilance Practices — QPPV, PSMF, case processing, signal management and aggregate reporting.
Pharmacovigilance built to EU GVP requirements.
A complete EU pharmacovigilance system — from the QPPV and the Pharmacovigilance System Master File to case processing, signal management and inspection readiness — established and run to the standards regulators actually inspect against.
For marketing-authorisation holders, virtual and small pharma, generics, importers and licensing partners who need a compliant PV system without building one in-house.
PV System & Quality System
Design and operation of a compliant pharmacovigilance system with its own quality system, defined roles, SOPs and performance monitoring.
Build my PV system →QPPV & Deputy
An appropriately qualified person responsible for pharmacovigilance who resides and operates in the EU, continuously available and with real authority over the safety system.
Appoint a QPPV →PSMF
Pharmacovigilance System Master File authored, located in the EU and kept permanently current — the reference document inspectors compare actual practice against.
Prepare my PSMF →ICSR Processing & EudraVigilance
Adverse-event intake, case processing, medical assessment, coding and expedited reporting to EudraVigilance within regulatory timelines (serious cases ≤ 15 days).
Outsource case handling →Signal Management
Detection, validation, assessment and documented follow-up of safety signals, with defined timelines and QPPV oversight.
Set up signal detection →Risk Management Plans
RMPs developed and maintained across the product lifecycle, including risk-minimisation measures and evaluation of their effectiveness.
Develop an RMP →PSUR / PBRER Reporting
Periodic safety update and benefit-risk reports prepared, quality-checked and submitted on schedule through the EU repository.
Plan aggregate reports →PV Audits & Inspection Readiness
Risk-based PV audits, vendor and partner oversight, CAPA and full readiness for EMA and national competent-authority pharmacovigilance inspections.
Get inspection-ready →Adverse-event reporting, the way EU law expects.
As a marketing-authorisation holder, European Pharma Experts records and reports suspected adverse reactions and gives patients and healthcare professionals a clear route to report them. Reporting suspected side effects helps provide more information on the safety of medicines.
Pharmacovigilance: info@europeanpharmaexperts.com
Bring your medicine to Europe, compliantly.
Tell us about your product and target markets — we’ll map the fastest compliant route to authorisation and supply.