Ensuring a Fully Compliant PV System for
a Successful Product Launch
a Successful Product Launch
A robust pharmacovigilance (PV) system is essential before launching a product to ensure regulatory compliance, patient safety, and smooth market entry. We provide end-to-end PV support to establish a fully functional system that meets all global and regional regulatory requirements. From setting up QPPV oversight and local PV operations to ensuring compliance with safety reporting, risk management, and regulatory submissions, we help you navigate the complexities of PV readiness for a seamless product launch.
Our PV Requirements for Product Launch leads
Seema Jaitly
Pharmacovigilance Physician
Bill Richardson
Pharmacovigilance Physician
Bridget King
Pharmacovigilance Consultant, Risk Management
Shelley Forword
PV Consultant, QPPV/LSO Management & PV Systems
Varsha Vasi
Pharmacovigilance Physician
Our QPPV & Local PV Services
Strategic PV Framework & Compliance
- PV Operating Model Development – Designing a scalable and compliant PV structure.
- Safety Governance Model Implementation – Establishing oversight for safety compliance.
- Cross-Functional Alignment – Ensuring seamless collaboration between PV, regulatory, clinical, and commercial teams.
- Local Country Requirements Compliance – Addressing country-specific pharmacovigilance obligations.
Safety Data, Reporting & Risk Management
- ICSR Reporting Compliance – Ensuring timely and accurate safety reporting.
- Sources of PV Data Assessment – Identifying and integrating key safety data sources.
- Implementation of RMM/REMs – Setting up Risk Minimization Measures (RMM) and Risk Evaluation and Mitigation Strategies (REMs) to enhance patient safety.
Operational Integration & Vendor Management
- Medical Information (MI) Set-up Support – Ensuring MI integration into the PV system.
- Integration of Business Partners (BPs) – Aligning PV responsibilities with licensing and distribution partners.
- Quality Management System (QMS) Development – Growing and maintaining a compliant QMS for continuous improvement.
- Ongoing Vendor Management – Assisting with the oversight of PV vendors to ensure compliance and operational efficiency.
Technology & Systems Optimisation
- Implementation of PV Systems & Technology – Supporting automation, data migration, and regulatory reporting tools.
