PSMF
Pharmacovigilance System Master File
The Pharmacovigilance System Master File (PSMF) is of central importance as pharmacovigilance master documentation.
It provides an overview of the entire pharmacovigilance system, while at the same time the document and the associated annexes reflect the safety information available worldwide for medicinal products authorized in the EU.
The structure and content of the PSMF are defined in detail in “Module II – Pharmacovigilance system master file” of the Guideline on good pharmacovigilance practices (GVP).
Depending on your company’s specific needs, we can create a comprehensive PSMF for you – incl.
annexes – in accordance with the regulatory requirements or support you selectively in the review and revision of SOPs and the description of pharmacovigilance-specific processes.
The documents we create are always delivered in an editable format (e.g. RTF, Word) so that you can easily edit the documents within your company.
Our portfolio in the PSMF area includes, among other things:
- Preparation of pharmacovigilance master documentation in accordance with Good Pharmacovigilance Practices (GVP), taking into account company-specific requirements
- Creation of the “Summary” document
- Review of the client’s SOPs and suggestions for improvement
- Assistance with the creation of an SOP for managing and maintaining the PSMF
Many of our customers take advantage of the opportunity to combine the creation of the PSMF with a “friendly audit” to optimize documentation and processes.
