PSURs

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

In line with your company-specific needs, we offer you both the preparation of individual PSURs and cross-company, pooled PSURs in the form of PSUR templates. In terms of content, the reports are prepared in accordance with GVP Module VII and provided in an editable format.

PSUR template

This is an active-substance-based PSUR template – it includes, among others:

• Extensive text modules
• Summary Tabulations of literature cases
• Published studies
• Bibliography

Individual PSUR

An individual PSUR is prepared by us in accordance with Good Pharmacovigilance Practices (GVP Guideline) and, taking MAH-specific data into account, is “ready for submission”. It includes, among others:

• Published studies
• Company-specific information (spontaneous reports, including line listings, Summary Tabulations and Narratives, sales figures, authorisation data)
• Texts and analyses (including the benefit-risk analysis)
• Bibliography