Expert Development Safety Update Report (DSUR) Authoring
At Soterius, our experienced medical writing team provides comprehensive support in authoring Development Safety Update Reports (DSURs), essential documents that consolidate critical safety data for drugs in clinical development. We help sponsors transition smoothly from older formats like the US IND Annual Report and EU Annual Safety Report to the standardized DSUR, ensuring regulatory compliance across global regions.
End-to-End DSUR Preparation and Submission
Our specialized DSUR services include meticulous preparation, thorough medical review, sponsor approval coordination, and timely regulatory submission. By carefully analyzing and clearly presenting critical safety findings—such as consistency with previous safety knowledge, identification of emerging risks, and effectiveness of existing risk management strategies—we empower sponsors to meet regulatory expectations and proactively address safety concerns.
