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)