Aggregate reporting

Aggregate Reporting

Our regulatory experts will work with you throughout the product lifecycle.

We can work on a report in full entirety or a specific section. The following are the reports that we can work on as a comprehensive solution to you aggregate reporting needs.

  • Periodic benefit/risk evaluation reports (PBRERs)
  • Periodic safety update reports (PSURs)
  • Developmental safety update reports (DSURs)
  • Periodic adverse drug experience reports (PADERs)
  • Support for risk management plans (RMPs) and risk evaluation and mitigation strategy (REMS)