Global & Local Pharmacovigilance
We build global PV systems fully compliant with international standards (ICH, GVP) and act as local LPPV representatives in 15+ countries.
ServicesGlobal-standard pharmacovigilance and drug safety solutions.
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.
ServicesWe assume marketing authorisation holders' legal obligations with our EU QPPV, UK QPPV, and country-based qualified person (LPPV) services.
ServicesFull-scope support for creating, maintaining, and keeping the Pharmacovigilance System Master File (PSMF) inspection-ready at all times.
ServicesCollection, assessment, coding (MedDRA), and electronic submission of Individual Case Safety Reports (ICSR) to systems such as EudraVigilance and FDA FAERS.
ServicesProactive signal detection, benefit-risk analysis, and the preparation of periodic safety reports (PBRER / DSUR).
ServicesOur validated safety database unifies ICSR management, coding, and regulatory submissions on a single platform.
ServicesWe combine compliance, technology, and a human-centric service approach under one roof.
We operate with field teams in 15+ countries, ensuring full compliance with local regulatory requirements.
Validated safety database and literature monitoring platforms automate and streamline your processes.
With robust PSMF management, SOPs, and quality processes, you are always ready for regulatory inspections.
Our expert staff scales flexibly with the size of your project, optimising your operational costs.
Talk to our team and let us design a tailored solution for you.
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