PSMF

As the pharmacovigilance master documentation, the Pharmacovigilance System Master File (PSMF) is of central importance. Here the entire pharmacovigilance system is described in overview; at the same time, the document and the associated annexes reflect the safety information available worldwide for medicinal products authorised in the EU.

The structure and content of the PSMF are laid down in detail in “Module II – Pharmacovigilance system master file” of the Guideline on good pharmacovigilance practices (GVP).

Depending on company-specific needs, we prepare for you a comprehensive PSMF – including the annexes – in accordance with the regulatory requirements, or we support you selectively in reviewing and revising the SOPs as well as describing pharmacovigilance-specific processes. The documents we prepare are generally delivered in an editable format (e.g. RTF, Word), so that you can easily continue to work on the documents in-house.

Our portfolio in the area of PSMF includes, among others

• Preparation of a pharmacovigilance master documentation in accordance with Good Pharmacovigilance Practices (GVP), taking company-specific needs into account
• Preparation of the “Summary” document
• Review of the client's SOPs and suggestions for improvement
• Assistance in preparing an SOP for the administration and maintenance of the PSMF

Many of our clients take the opportunity to combine the preparation of the PSMF with a “Friendly Audit” to optimise documentation and processes.