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Regulatory Submission Preparator

FDA Submission Package - Phase II Trial CTX-29845

In Progress

Package generation in progress - 6 of 8 sections complete

AI Assistant
I've analyzed your trial documentation and prepared your FDA submission package. I've identified 2 potential issues that need your attention.
75%
1. Form FDA 1571
Completed
2. Table of Contents
Completed
3. Introductory Statement
Completed
4. General Investigational Plan
Completed
5. Investigator's Brochure
Completed
6. Clinical Protocol
Completed
7. Chemistry, Manufacturing, and Control Information
Missing Data

AI analysis detected missing stability data for batch CTX-29845-B3.

8. Pharmacology and Toxicology Information
Needs Review

AI detected potential inconsistency between toxicity data in Section 3.4 and safety data in Appendix B.

Document Consistency Check

AI-powered verification of cross-referenced information

Consistent References
43
Potential Conflicts
2
Critical Issues
0

AI Detected Potential Conflict

The dosage information in the Clinical Protocol (Section 4.2) lists 15mg twice daily, but the Investigator's Brochure (Page 24) references 15mg once daily.

AI Recommendation

Based on the overall documentation, it appears the Clinical Protocol contains the correct dosage information. I recommend updating the Investigator's Brochure to maintain consistency.

Submission Requirements

FDA IND Application Checklist

Core Documents
6/6 Complete
CMC Documentation
7/8 Complete
Safety Documentation
12/12 Complete
Administrative Forms
4/4 Complete

AI Assistant

Ask questions about your submission

You
What sections are commonly rejected by the FDA in IND applications?
Based on FDA data, CMC (Chemistry, Manufacturing, and Control) information is most frequently cited in IND clinical holds, particularly regarding drug substance and product quality, stability data, and manufacturing processes. I've already identified a potential issue with your CMC section that you should address.
You
When is the earliest we can submit this application?
Based on your current documentation status, you can submit as early as June 5, 2025, assuming you resolve the CMC documentation issue and review the potential conflict in the pharmacology section within the next 7 days. Would you like me to help you prioritize the remaining tasks?

Submission Timeline

AI-generated timeline prediction

Documentation Collection
Completed April 12, 2025
Initial AI Processing
Completed April 15, 2025
Documentation Completion
Estimated April 27, 2025
Final Review
Estimated May 10, 2025
Submission Ready
Estimated June 1, 2025
AI Insight: Based on historical FDA review patterns, submitting by early June would position your application for review before the July advisory committee meeting.
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