AGGREGATE REPORT WRITING
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)
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