We support safety-related document authoring throughout the drug development lifecycle for all major global agencies. This includes safety narratives, eCTD documents (2.7.4, ISS), aggregate reports, risk management plans, cumulative safety analysis, literature searches, global value dossiers, and signal evaluations.
- DSUR/IND Annual Report
- Addendum to Clinical Overview
- Signal assessment report
- Safety analysis document/report
- Benefit-Risk Analysis