Set-Up
Your products and reporting rules are configured in the database.
A single platform for ICSR management, coding and regulatory submissions.
A pharmacovigilance safety database stores individual cases, supports MedDRA coding and generates the electronic reports and listings required by authorities.
URAS PV's validated safety database unifies ICSR management, coding and regulatory submissions on a single platform, so your safety data is consistent, traceable and ready for analysis.
Your products and reporting rules are configured in the database.
Cases are processed with full traceability and controlled access.
Submissions, listings and outputs are generated from one source.
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 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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