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Ind Application

Draft FDA IND Applications in Minutes, Not Hours

15 minutes with CaseMark

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Ind Application

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Workflow

Ind Application

Overview

CaseMark's IND Application skill uses AI to draft complete Investigational New Drug applications under 21 CFR Part 312, transforming raw nonclinical data, CMC documentation, and clinical protocols into a structured FDA submission package. The tool generates every major section—from the Form 1571 cover sheet through pharmacology/toxicology summaries—following the precise regulatory framework required for clinical trial authorization.

Preparing an IND application is one of the most document-intensive tasks in drug development. Regulatory teams spend weeks manually compiling nonclinical reports, CMC data, clinical protocols, and investigator information into a cohesive submission that meets FDA requirements under 21 CFR Part 312. Missed cross-references, inconsistent formatting, and compliance gaps can delay clinical trial authorization by months.

CaseMark automates the heavy lifting of IND application drafting by ingesting your source documents and generating a complete, structured submission package aligned with 21 CFR 312.23(a). The AI organizes content into the correct regulatory sections, cross-references citations, and flags potential compliance gaps—giving your regulatory team a polished first draft to review and finalize rather than build from scratch.

How it works

  1. 1. Upload your nonclinical reports, CMC data, clinical protocols, and investigator documentation

  2. 2. AI analyzes and organizes content into the 21 CFR 312.23(a) section framework

  3. 3. Review and customize each IND section, including Form 1571 and Investigator's Brochure

  4. 4. Export the complete IND application package in your preferred format (DOCX, PDF)

What you get

  • Form 1571 Cover Sheet

  • Table of Contents

  • Introductory Statement & Investigational Plan

  • Investigator's Brochure

  • Clinical Protocol Summary

  • CMC: Drug Substance Section

  • CMC: Drug Product Section

  • Pharmacology & Toxicology Summary

  • Previous Human Experience Section

  • Cross-Reference Index & Compliance Checklist

What it handles

  • Generates complete IND structure following 21 CFR 312.23(a) section order

  • Drafts Form 1571 cover sheet with auto-populated fields

  • Produces Investigator's Brochure with safety, efficacy, and pharmacology summaries

  • Compiles CMC sections for drug substance and drug product

  • Synthesizes nonclinical pharmacology and toxicology data packages

  • Cross-references citations across IND sections for regulatory consistency

Required documents

  • Nonclinical Study Reports

    Pharmacology, toxicology, and PK/PD study reports supporting the investigational drug

    .pdf, .docx

  • CMC Documentation

    Manufacturing process descriptions, specifications, stability data, and certificates of analysis for drug substance and product

    .pdf, .docx

  • Clinical Protocol

    Study design, objectives, endpoints, dosing, safety monitoring plan, and statistical analysis plan

    .pdf, .docx

Supporting documents

  • Investigator CVs and Form 1572

    Investigator qualifications, signed Form FDA 1572, and clinical site details

    .pdf, .docx

  • Prior Human Experience Data

    Foreign clinical trial reports, published literature, or compassionate use data

    .pdf, .docx

  • IRB Documentation

    IRB approval letters, submission plans, and informed consent form templates

    .pdf, .docx

  • Drug Substance Information

    Chemical name, structural formula, code designation, and mechanism of action details

    .pdf, .docx

Why teams use it

Reduce IND drafting time from weeks to hours with AI-generated first drafts that follow 21 CFR 312.23(a) structure

Minimize compliance gaps with built-in checklists for Form 1571, Investigator's Brochure, and clinical protocol requirements

Ensure consistent cross-referencing across nonclinical, CMC, and clinical sections throughout the application

Scale efficiently across Phase I, II, and III submissions with phase-appropriate content depth

Questions

What sections of the IND application does CaseMark generate?

CaseMark drafts all major sections required under 21 CFR 312.23(a), including the Form 1571 cover sheet, table of contents, introductory statement, Investigator's Brochure, clinical protocols, CMC sections for drug substance and product, pharmacology/toxicology summaries, and previous human experience. Each section follows FDA regulatory numbering conventions.

Can CaseMark handle IND applications for different trial phases?

Yes. CaseMark adapts the depth and detail of CMC, nonclinical, and clinical sections based on the trial phase (Phase I, II, or III). Phase I applications receive appropriately scaled CMC and toxicology sections, while later-phase submissions include more comprehensive data packages.

Does CaseMark replace the need for regulatory counsel or consultants?

CaseMark is designed to accelerate the drafting process, not replace expert regulatory judgment. The AI generates a comprehensive first draft that regulatory affairs professionals, attorneys, and consultants can review, refine, and finalize before submission to the FDA.

Can I use CaseMark for pre-IND packages and IND amendments?

Absolutely. CaseMark supports pre-IND meeting packages, original IND submissions, IND amendments, and clinical trial authorization documents. You can tailor the output scope to match your specific submission needs.

How does CaseMark ensure compliance with 21 CFR Part 312?

CaseMark structures every output according to the section order and content requirements specified in 21 CFR 312.23(a). It includes built-in compliance checklists for Form 1571, the Investigator's Brochure, clinical protocols, and environmental assessments to help identify gaps before submission.

What file formats can I upload and export?

You can upload source documents in PDF, DOCX, and other common formats. CaseMark exports the completed IND application package as DOCX or PDF, ready for final review and FDA submission.

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