PSMF Setup and Maintenance
Committed to maintaining pharmacovigilance system master file (PSMF) integrity, our services encompass the establishment and continuous upkeep of comprehensive documentation. We strive for regulatory compliance and the highest standards of pharmacovigilance practice.
End-to End PSMF Development and Management
The Pharmacovigilance System Master File (PSMF) is a comprehensive document that provides regulators with essential information about your pharmacovigilance system’s structure, processes, and performance.
At Qinecsa, our professionals are experts in creating accurate, compliant PSMFs both for EU and ROW regions that meet your specific organisational structure and products. Knowledgeable and responsive, our dedicated specialists will develop master files that satisfy regulatory requirements and accurately reflect your pharmacovigilance activities.
We also understand that maintaining an accurate, up-to-date PSMF requires ongoing attention. Our maintenance services provide systematic monitoring and timely updates to ensure continuous compliance, including:
- Regular review and revision cycles
- Change implementation and documentation
- Performance indicator updates
- Annex management and maintenance
- Contract revision and documentation
- Audit and inspection readiness
- System change management
For organisations with existing PSMFs, we are more than happy to conduct thorough gap analyses to identify compliance deficiencies and improvement opportunities.
End-to-end support in the compilation and maintenance of the PSMF accurately reflecting the pharmacovigilance system applicable to the product(s).
Up-To-Date Information
Continuous oversight and upkeep of the information to maintain an audit/inspection ready PSMF for the QPPV and the authorities.
Access to the PSMF
Immediate access to the PSMF can be provided if required by the competent authorities, at the stated PSMF location or QPPV site.
Change Control Process
Active solicitation of all changes including organizational changes, contractual changes, takeovers/mergers, delegation/ transfers for pharmacovigilance activities from the marketing authorization holder (MAH), ensuring a robust change control mechanism for the PSMF information.
Continuous Support and Inspection Readiness
At Qinecsa, our PSMF services include specific preparation for audits and regulatory inspections through mock reviews, readiness assessments, and targeted enhancement initiatives. We ensure your PSMF not only meets technical requirements but also effectively communicates your system’s quality and effectiveness.
Working with Qinecsa for Your PSMF Needs
We aim to create advanced, reliable solutions that achieve compliance and world-class client engagement. Gain the confidence in navigating your regulatory compliance with Qinecsa managing your PSMF needs, so you can focus on core pharmacovigilance activities. Our comprehensive understanding of evolving regulatory expectations ensures your PSMF remains current and inspection-ready at all times.
