Assessment
We review your PV system, procedures and existing documentation.
Writing your global Pharmacovigilance System Master File, keeping it current and inspection-ready at all times.
The Pharmacovigilance System Master File (PSMF) describes the pharmacovigilance system used by the marketing authorisation holder for its authorised products. Its content and maintenance are described in GVP Module II.
URAS PV writes the global PSMF and its annexes, prepares national or local versions where local legislation requires them, keeps the file up to date as your system changes, and makes sure it can be provided to competent authorities whenever requested.
We review your PV system, procedures and existing documentation.
We write or restructure the global PSMF and its annexes.
We record changes and keep the PSMF current and inspection-ready.
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 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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