Pharmacovigilance System Master File Management

Pharmacovigilance System Master File (PSMF) Management

Comprehensive support in developing and maintaining your
pharmacovigilance system master file to ensure full regulatory
requirements and patient safety.

PSMF in the EU PV System: Purpose and Scope

The Master File for the Pharmacovigilance System is a key document that provides an overview of the safety system infrastructure for delivering drug safety. This document is intended to assist regulatory authorities in understanding the manufacturer's drug safety monitoring and management. By utilising expert pharmacovigilance system master file solutions, companies can effectively document key components, including the QPPV’s responsibilities, organisational structure, safety databases, and quality management processes. This ensures the system remains transparent, audit-ready, and fully aligned with GVP requirements.

Our Pharmacovigilance System Master File Services

We provide comprehensive support for the pharmacovigilance system master file (PSMF), ensuring your documentation is compliant, accurate, and audit-ready. Our team handles everything from initial creation to strategic PSMF management for global markets.

PSMF Authoring (End-to-End Build)

We handle the complete development of your system master file PSMF, from drafting the main body to compiling annexes. Our experts ensure that every pharmacovigilance system master detail meets the requirements, including all of the necessary sections.

PSMF Gap Assessment and Remediation

To stay in compliance and find gaps, our team does a deep-dive analysis. We make sure that your pharmacovigilance system master documentation meets the current requirements in your area. This gives you a PSMF solution that makes sure all safety information is recorded and reported correctly.

Lifecycle Management and Continuous Updates

PSMFs require ongoing maintenance to remain valid. We manage the PSMF process, implementing updates for changes in the qualified person responsible for pharmacovigilance, ensuring your system master remains a living document that accurately tracks all system changes.

Inspection Readiness Support (Mock Inspection, Evidence Pack)

We prepare you for scrutiny by ensuring your system master file is audit-ready. Our support includes preparing the qualified person for interviews and verifying that all pharmacovigilance standard operating procedures are correctly cross-referenced.

DrugCard Platform in Numbers

121+

Countries
Medical journals coverage

2200+

Local journals
Continuously monitored

Weeks
New country Easily Added

What We Deliver as Pharmacovigilance System Master File Solutions

We give you a PSMF that is fully compliant and ready for an audit, and that is made to fit your business. Our deliverables include a well-organized main body, all required annexes, and a strong maintenance plan to make sure that your documents are always correct and approved by the regulators.

PSMF Document and Annexes (Structured, Traceable, Audit-Ready)

We give you a master file and annexes that are logically organized, so that every detail can be tracked and is ready for any competent authority inspection.

Document Control: Versioning, Change Log, Ownership

Our system keeps a clear, historical record of how your pharmacovigilance system has changed over time by using precise versioning, detailed change logs, and clear ownership.

Evidence Mapping: SOPs, Quality Records, Contracts, Metrics

We align your system master file with internal standard operating procedures, quality records, and metrics to demonstrate a high-functioning and compliant safety system.

How We Build and Maintain Your Pharmacovigilance System Master File

Our structured method makes sure that your PSMF is built correctly, showing how your business works while still following all of the changing global rules.

Discovery

We start by checking your infrastructure, finding the right responsible people, and collecting information from safety databases, contracts, and pharmacovigilance activities.

Content Drafting and Stakeholder Review Cycles

Our experts write the main body and annexes, and then they start a series of reviews with your team to make sure that every technical detail is correct and clinically sound.

Quality Checks and Consistency Validation

We do strict quality checks to make sure that the data is consistent across all sections and that your SOPs, metrics, and organizational charts all match up perfectly with the PSMF.

Handover or Managed Service Model

Choose between a complete handover of the final document or a managed service model where we provide ongoing updates and lifecycle maintenance for your system.

Engagement Options

We have flexible engagement models that can be customized to meet the needs of your business. Our team will work with your internal processes to set up a one-time PSMF for a new marketing authorization or a long-term managed service for ongoing lifecycle maintenance. We offer scalable solutions for both new and established MAHs, making sure that compliance is affordable and professional oversight is available.

Timeline, Inputs, and What We Need From You

A standard PSMF build typically takes 4 to 8 weeks, depending on system complexity. To begin, we require access to your QPPV details, safety database descriptions, organizational charts, and existing PV agreements. Your active participation during stakeholder review cycles is essential to ensure the document accurately reflects your operational reality and quality standards.

Why Choose DrugCard?

DrugCard provides deep expertise in GVP-compliant documentation, ensuring high-quality, audit-ready files that meet the most rigorous regulatory standards. When you choose our solutions, your safety processes will work smoothly with our automated monitoring tools. This will help you stay ahead of changes in the law and keep your pharmacovigilance system up to date and free of risk.

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