We author, structure and maintain your Pharmacovigilance System Master File so it remains a single, accurate and inspection-ready description of your entire PV system.
PSMF Creation & Maintenance
Expert drafting, structuring and ongoing maintenance of your PSMF, ensuring it is always inspection-ready and fully compliant with EMA, MHRA, FDA and global requirements.
Regulatory Compliance & Updates
Continuous monitoring and timely updates to your PSMF in line with evolving regulations, product changes and organisational updates.
Audit & Inspection Support
Comprehensive support during audits and inspections, including gap analysis, document review and rapid response to authority queries.
Global PSMF Integration
Seamless integration of PSMF requirements across multiple markets and affiliates, ensuring consistency and transparency worldwide.
Data Integrity & Security
Robust systems and processes to ensure the accuracy, confidentiality and security of all PSMF data and supporting documentation.
QPPV & PV System Linkage
Clear documentation and linkage of QPPV responsibilities, PV system structure and partner relationships within your PSMF.
Document Control & Versioning
Advanced document management for version control, audit trails and rapid retrieval of PSMF sections during authority requests.
Continuous Expert Support
Ongoing consultation and support for all PSMF-related needs, from initial setup to lifecycle management and authority interactions.
