Pharmacovigilance System Master File (PSMF)

The Pharmacovigilance System Master File (PSMF) as pharmacovigilance master documentation is of central importance. Here, the entire pharmacovigilance system is described at a glance. At the same time, the document and its annexes reflect the safety information for medicinal products authorised in the EU, which is available worldwide.

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


Depending on your company-specific needs, we will prepare a comprehensive PSMF for you – including the annexes – in accordance with the regulatory requirements or provide you with selective support in the review and revision of SOPs as well as 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 process them within your company.


Our portfolio in the area of PSMF includes:

    • The preparation of pharmacovigilance master documentation according to Good Pharmacovigilance Practices (GVP)
    • The preparation of the “Summary” document
    • Assistance in the creation of a SOP for the administration and maintenance of the PSMF


Would you like to know more?

We are pleased that you are interested in our PSMF services. We would be happy to present our services in detail – just contact us.