Aggregate Reports
DSUR, PSUR, and PADER generation with AI-assisted drafting
Human-Reviewed Outputs
Report Generation Workflow
DC
Data Cleaning
completed
DD
Deduplication
completed
VL
Validation
completed
DR
Draft
active
QC
QC Review
pending
SB
Submit
pending
DSUR-2024-001
DSUR
eCTD
DrugX 100mg — Jan 2023 – Dec 2023
In Draft
v2.1
Due
2024-03-15
PSUR-2024-002
PSUR
E2C(R2)
DrugY 50mg — Jul 2023 – Dec 2023
QC Review
v1.3
Due
2024-02-28
PADER-2024-001
PADER
eCTD
DrugZ 25mg — Jan 2024 – Jun 2024
Submitted
v3.0
Due
2024-01-31
DSUR-2024-003
DSUR
eCTD
DrugA 200mg — Jan 2023 – Dec 2023
Data Cleaning
v0.1
Due
2024-04-30
Output Format Configuration
eCTD
Electronic Common Technical Document
E2C(R2)
Periodic Safety Update Report
NeeS
Non-eCTD Electronic Submissions
PDF/A
Archival PDF format