- PSUR Addendum Reports
- PSUR LL Reports
- SUSAR Reports (six-monthly)
- Drug Safety Reports/Ad-hoc reports
- PQC reports/HHEs
For all the reports above, we help determine strategy, review and analyze data/literature/signals, provide guidance, and review and implement comments.
Additional services, such as generation of listings for Aggregate Reports, Clinical Expert Statements and Independent Quality Reviews, are also offered.
- RMPs and RMP Updates
- Safety Narratives for Clinical Study Reports & Protocols
- Clinical Summaries/Product Feasibility Reports for Medical Devices
- Guided Questionnaires
- Company Core Safety Information