Periodic Safety Update Report (PSUR)

MYdossier is a global leader in regulatory consulting and Periodic Safety Update Report (PSUR) solution for export registration in CIS and other countries. We write and review Periodic Safety Update Report as per European CTD guideline.

Periodic Safety Update Report includes:
- Worldwide marketing authorization status
- Overview of exposure and safety data
- Actions taken in the reporting interval for safety reasons
- Changes to reference safety information
- Estimated exposure and use patterns
- Summaries of significant findings from clinical trials in the reporting interval
- Findings from non-interventional studies
- Information from other clinical trials and sources
- Non-clinical data
- Literature
- Discussion and conclusions on PSUR data

We are capable to prepare dossier for more than 90 countries.

For PSUR service write email to