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 support in the compilation and maintenance of the PSMF accurately reflecting the pharmacovigilance system applicable to the product(s).
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.