Global & Local Pharmacovigilance
We build global PV systems fully compliant with international standards (ICH, GVP) and act as local LPPV representatives in 15+ countries.
Global and local pharmacovigilance detailsEnd-to-end pharmacovigilance services, from QPPV and PSMF to case processing, signal management and audits, for global and local markets.
From pre-authorisation to lifecycle management, we stand by you in every phase.
We build global PV systems fully compliant with international standards (ICH, GVP) and act as local LPPV representatives in 15+ countries.
Global and local pharmacovigilance detailsWe assume marketing authorisation holders' legal obligations with our EU QPPV, UK QPPV, and country-based qualified person (LPPV) services.
QPPV outsourcing detailsFull-scope support for creating, maintaining, and keeping the Pharmacovigilance System Master File (PSMF) inspection-ready at all times.
PSMF writing and management detailsWriting and review of pharmacovigilance SOPs and working instructions aligned with GVP and local requirements.
SOP writing detailsCollection, assessment, coding (MedDRA), and electronic submission of Individual Case Safety Reports (ICSR) to systems such as EudraVigilance and FDA FAERS.
ICSR processing detailsProactive signal detection, benefit-risk analysis, and the preparation of periodic safety reports (PBRER / DSUR).
Signal management detailsContinuous monitoring of global and local literature (PubMed + local journals), case identification, and reporting.
Literature monitoring detailsOur validated safety database unifies ICSR management, coding, and regulatory submissions on a single platform.
Safety database detailsPV audit preparation, internal audit services, and regulatory training programmes for your teams.
Audit and training detailsOur expertise includes Local QPPV and EAEU QPPV services, Individual Case Safety Report (ICSR) management, local literature monitoring, pharmacovigilance system documentation, and regulatory support.
Pharmacovigilance across the CIS and TürkiyeTalk to our team and let us design a tailored solution for you.
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