Our experts can manage all Aggregate Report writing assignments which are required during clinical development, and post marketing. We have a though understanding of the DLP calendar, Annual and periodic reports requirements.
Our expertise are;
- DSUR (Development Safety Update Reports)
- PSUR (Periodic Safety Update Reports)
- PBRER (Periodic Benefit-Risk Evaluation Reports)
- PADERs (Periodic Adverse Drug Experience Reports)
- Addendum to the Clinical Overviews (ACOs) for module 2.5 for MA renewals
- RMP (Risk Management Plans) as per the EU-RMP template and region-specific appendices
- REMS (Risk Evaluation and Mitigation Strategies) as per US FDA requirements