Expert drafting, structuring, and ongoing maintenance of your Pharmacovigilance System Master File, ensuring it is always inspection-ready and fully compliant with EMA, FDA, and global requirements.
Continuous monitoring and timely updates to your PSMF in line with evolving regulations, product changes, and organizational updates.
Comprehensive support during audits and inspections, including gap analysis, document review, and rapid response to authority queries.
Seamless integration of PSMF requirements across multiple markets and affiliates, ensuring consistency and transparency worldwide.
Robust systems and processes to ensure the accuracy, confidentiality, and security of all PSMF data and supporting documentation.
Clear documentation and linkage of QPPV responsibilities, PV system structure, and partner relationships within your PSMF.
Advanced document management for version control, audit trails, and rapid retrieval of PSMF sections during authority requests.
Ongoing consultation and support for all PSMF-related needs, from initial setup to lifecycle management and authority interactions.