Gap Assessment
We review your current PV system and local obligations in each target market.
A pharmacovigilance system that meets international standards and the local requirements of every market where your products are authorised.
Marketing authorisation holders must operate a pharmacovigilance system that complies with international guidance such as ICH and EU Good Pharmacovigilance Practices (GVP), while also meeting the national requirements of each country where their products are marketed.
URAS PV builds and operates global PV systems and acts as the local pharmacovigilance contact (LPPV) in the markets we cover, so that global processes and local obligations work together.
We review your current PV system and local obligations in each target market.
We define processes, responsibilities and data flows between global and local teams.
We run day-to-day PV activities and keep you informed of regulatory changes.
We 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 detailsAn overview of our end-to-end pharmacovigilance services.
All pharmacovigilance servicesTalk to our team and let us design a tailored solution for you.
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