Optimising Your PV System
for Compliance & Regulatory Excellence
for Compliance & Regulatory Excellence
We assess and enhance your current pharmacovigilance (PV) system to ensure full compliance with global guidelines and regulatory requirements. Our approach identifies gaps, strengthens processes, and builds a robust PV framework that aligns with industry best practices. Whether you need a comprehensive system review or strategic improvements, we help you maintain compliance while optimizing efficiency and patient safety.
Our Safety Operations and PV System Build leads
Seema Jaitly
Pharmacovigilance Physician
Shelley Forword
PV Consultant, QPPV/LSO Management & PV Systems
Our PV System Optimisation Services
PV System Assessment & Enhancement
- Gap Analysis of PV System – Identifying compliance risks and improvement opportunities.
- PV System Assessment, Design & Implementation – Establishing a structured and compliant PV framework.
- Safety Governance Models – Developing governance structures for effective oversight.
Regulatory Documentation & Compliance
- Authoring EU & Regional Pharmacovigilance System Master Files (PSMFs) – Ensuring alignment with EU and country-specific requirements.
- PV & GCP Quality Management System (QMS) Setup – Building compliant and efficient quality frameworks.
Vendor & Data Management
- PV Vendor Selection & RFP Management – Supporting vendor evaluation and selection.
- Vendor Oversight – Ensuring proper monitoring and governance of outsourced PV functions.
- Migration & Validation of Safety Data – Secure and compliant data transition and validation.
Regulatory Intelligence & Strategy
- Regulatory Intelligence – Keeping you informed of evolving regulations and compliance requirements.
