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Forecast
Active submissions
34
Inspection-ready trials
21/24
Median draft time
3.2d
↓ 71% vs. baseline
Open agency queries
6
Submission pipeline
Generate new
IND-128445
IND amendment
ONCO-204 · FDA · Due Aug 14
62%
Drafting
Open dossier
CTA-EU-204
CTA submission
ONCO-204 · EMA (CTIS) · Due Submitted
100%
Under review
Open dossier
IB-307-v4
Investigator Brochure
ONCO-307 · Multi · Due Jul 30
84%
Author review
Open dossier
DSUR-118
DSUR
RD-118 · FDA + EMA · Due Sep 02
41%
Generating
Open dossier
Inspection package — ONCO-204
Protocol & amendments
Complete
Investigator Brochure v4.2
Complete
Informed Consent (24 languages)
Complete
Site qualification records
Complete
Monitoring visit reports
Auto-generating
Deviation log & CAPA
Complete
Export inspection-ready ZIP
Recent agency intelligence
FDA
2d ago
New ICH E6(R3) GCP guidance impacts monitoring plans
EMA
5d ago
Revised pediatric investigation plan template
PMDA
1w ago
Updated submission timeline for oncology
MHRA
2w ago
Brexit-era post-authorization safety reporting reminder