Global & Local Pharmacovigilance
We build global PV systems fully compliant with international standards (ICH, GVP) and act as local LPPV representatives in 15+ countries.
End-to-end solutions covering every function of pharmacovigilance.
We build global PV systems fully compliant with international standards (ICH, GVP) and act as local LPPV representatives in 15+ countries.
We assume marketing authorisation holders' legal obligations with our EU QPPV, UK QPPV, and country-based qualified person (LPPV) services.
Full-scope support for creating, maintaining, and keeping the Pharmacovigilance System Master File (PSMF) inspection-ready at all times.
Collection, assessment, coding (MedDRA), and electronic submission of Individual Case Safety Reports (ICSR) to systems such as EudraVigilance and FDA FAERS.
Proactive signal detection, benefit-risk analysis, and the preparation of periodic safety reports (PBRER / DSUR).
Continuous monitoring of global and local literature (PubMed + local journals), case identification, and reporting.
Our validated safety database unifies ICSR management, coding, and regulatory submissions on a single platform.
PV audit preparation, internal audit services, and regulatory training programmes for your teams.
Talk to our team and let us design a tailored solution for you.
Request a Free Assessment