In 2010, the International Conference on Harmonization (ICH) launched its E2F on Development Safety Update Reports (DSUR). A DSUR is similar to the Investigational New Drug Annual Report (IND-AR) in the US and the European Annual Safety Report (ASR). The purpose of this document is to provide a general safety review on an annual basis. The ICH guideline can be found here.
We can prepare your reports ready for submission. We have extensive experience in preparing high quality DSURs to ensure compliance with the existing requirements. Moreover, we can organise the clinical review and sign off and published literature summary/analysis.
If you want to dicuss how you can be safe in our hands, please contact us for a consultation.
Telephone: +353 125 44033