The Reports section provides five specialized reports that extract regulatory intelligence from your imported dossiers. Each report analyzes a different aspect of your submissions — from timeline history to drug specifications to agency correspondence.
Reports hub showing all five report tiles
Accessing Reports #
Click Reports in the sidebar. The Reports hub shows all available reports as clickable tiles.
Available Reports #
| Report | What It Answers | Status |
|---|---|---|
| Chronology Report | “What is the complete submission history for this dossier?” | Active |
| Correspondence Tracking | “What letters, meetings, and commitments exist with the agency?” | Active |
| Specification Dashboard | “What is the quality profile of this drug substance and product?” | Active |
| Labeling History Report | “How has the labeling changed across submissions?” | Active |
| Clinical Studies Report | “What clinical studies are in Module 5 and what are the key findings?” | Active |
| Portfolio Analytics | “How does my entire regulatory portfolio look across all dossiers?” | Coming Soon |
Which Report Should I Use? #
| I Need To… | Use This Report |
|---|---|
| See the full timeline of submissions for an application | Chronology Report |
| Track cover letters, meeting minutes, and FDA questions | Correspondence Tracking |
| Understand the drug specifications (purity, impurities, stability) | Specification Dashboard |
| Compare labeling versions across amendments | Labeling History Report |
| Review clinical study data and endpoints | Clinical Studies Report |
Common Across All Reports #
Every report shares these features:
- Application selector — Choose which dossier to analyze
- Export — Download results as a spreadsheet
- AI Enrich — Run AI analysis to extract and classify additional data from documents
- Refresh — Reload data (cached or full re-extraction)
Tip: Reports analyze documents that have already been imported. If you import a new submission, click Refresh → Full Re-extraction in the relevant report to include the new content.
