Periodic Safety Update Reports (PSURs)

PSURs are periodic reports in which the benefit-risk profile of a medicinal product is evaluated.

We offer you the creation of individual PSURs as well as cross-company, pooled PSURs in the form of PSUR templates according to your company-specific needs. The content of the reports is created in accordance with GVP Module VII and provided in an editable format.


  • Individual PSUR


    An individual PSUR is prepared in accordance with the Good Pharmacovigilance Practices (GVP) Guideline and is therefore “ready for delivery”. It includes:

      • Published studies
      • Company-specific information (spontaneous registrations, including line listings, summary tabulations and narratives, sales figures, and registration data)
      • Texts and analyses (including risk-benefit analysis)
  • Pooled PSUR


    This is an active-ingredient-related PSUR template – this includes, among other things:

      • Extensive text modules
      • Summary tabulations on literature cases
      • Published studies
      • Bibliography


Would you like to know more?

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