The purpose of Periodic safety update report (PSUR) is to provide safety assessment based on new data obtained after product’s authorization. Since this document is intended for regulatory authorities, the common accepted format of PSUR is designed to enable efficient evaluation of product’s overall benefit-risk profile.

Biomapas medical writers and pharmacovigilance specialist can support you in preparation of this document or prepare PSUR themselves in accordance to all relevant guidelines. The combined expertise of our specialists can ensure the high quality of the final document.