PSMF, SOPs and PVAs
PharmaPartner supports Clients to create all documents necessary to correct functioning of pharmacovigilance system, and to establish the processes necessary to their maintenance according to quality requirements.
Creation and update of:
- Pharmacovigilance System Master File – PSMF, complex document to be kept constantly updated- it must be provided to Regulatory Authority within 7 days upon request.
- Standard Operating Procedures – SOPs -, that help Companies to show compliance to laws and reproducibility of pharmacovigilance activities
- Pharmacovigilance Agreement – PVAs – defining roles and responsibilities in case of Licensing partners.
Maintenance of these documents, such us the conduction of several critical activities, requires full cooperation amongst different Company departments: PharmaPartner helps Clients to create efficient and effective information flows.