Gap Analysis
We compare your existing procedures with regulatory requirements and your PV activities.
Standard Operating Procedures that describe how your pharmacovigilance system works, written to meet regulatory expectations and the way your organisation operates.
A pharmacovigilance quality system relies on written procedures. Competent authorities expect marketing authorisation holders to have documented processes for their key pharmacovigilance activities; the pharmacovigilance quality system is described in GVP Module I.
URAS PV writes new SOPs, reviews existing ones against current requirements, and aligns global procedures with the local obligations of the markets you operate in.
We compare your existing procedures with regulatory requirements and your PV activities.
SOPs are drafted in a clear, consistent format and reviewed with your team.
Approved SOPs are rolled out with training and a schedule for periodic review.
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 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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