Thinki aggregate reporting team has expertise in reviewing and writing aggregate reports as per the relevant regulations in a cost efficient and timely manner. Some of the reports we write are:
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit Risk Evaluation Reports (PBRERs)
- Addendum Reports, Annual Safety Reports (ASRs) and Summary Bridging Reports, where needed
- Periodic Adverse Drug Experience Reports (PADERs)
- SUSAR Reports
- Development Safety Update Reports (DSURs)