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Ind Application

Draft FDA IND Applications in Minutes, Not Weeks

15 minutes with CaseMark

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Workflow

Ind Application

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Workflow

Ind Application

Overview

CaseMark's IND Application skill automates the drafting of FDA Investigational New Drug applications under 21 CFR Part 312. It transforms your nonclinical reports, CMC data, and clinical protocols into a structured, comprehensive IND submission package covering all required sections from Form 1571 through pharmacology and toxicology. The result is a regulatory-ready draft that dramatically reduces preparation time while maintaining compliance with FDA requirements.

Preparing an IND application is one of the most complex and time-intensive tasks in drug development. Regulatory teams spend weeks manually drafting, organizing, and cross-referencing dozens of documents across CMC, nonclinical, and clinical domains to meet 21 CFR Part 312 requirements. Errors in structure, missing cross-references, or inconsistent data presentation can delay FDA review and push back clinical trial timelines.

CaseMark's AI-powered IND Application skill ingests your source documents and automatically generates a complete, structured IND draft aligned with 21 CFR 312.23(a) requirements. From Form 1571 through the Investigator's Brochure, clinical protocols, and CMC sections, CaseMark ensures every section is properly organized, cross-referenced, and phase-appropriate — giving regulatory teams a polished starting point that accelerates the path to clinical trial authorization.

How it works

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

  2. 2. AI analyzes your documents and structures a complete IND application per 21 CFR 312.23(a)

  3. 3. Review and customize each section, from Form 1571 through pharmacology/toxicology

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

What you get

  • Form 1571 Cover Sheet

  • Table of Contents

  • Introductory Statement and Investigational Plan

  • Investigator's Brochure

  • Clinical Protocol(s) with Statistical Analysis Plan

  • CMC: Drug Substance Section

  • CMC: Drug Product Section

  • Pharmacology and Toxicology Data Package

  • Previous Human Experience Summary

  • Compliance Checklists

What it handles

  • Generates complete IND applications structured per 21 CFR 312.23(a) section order

  • Drafts Form 1571 cover sheet with auto-populated sponsor and drug information

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

  • Creates CMC sections for drug substance and drug product with specifications and stability data

  • Drafts clinical protocols with study design, dosing, endpoints, and statistical analysis plans

  • Compiles nonclinical pharmacology and toxicology data packages with cross-referenced citations

Required documents

  • Nonclinical Study Reports

    Pharmacology, toxicology, and PK/PD study reports supporting the IND submission

    .pdf, .docx

  • CMC Data Package

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

    .pdf, .docx

  • Clinical Protocol Documents

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

    .pdf, .docx

Supporting documents

  • Investigator Information

    Investigator CVs, Form FDA 1572, and clinical site details

    .pdf, .docx

  • Prior Human Experience Data

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

    .pdf, .docx

  • IRB Documentation

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

    .pdf, .docx

  • Drug Substance Information

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

    .pdf, .docx

Why teams use it

Reduce IND preparation time from weeks to hours by automating the drafting of all major submission sections

Ensure structural compliance with 21 CFR 312.23(a) section ordering and content requirements

Maintain internal consistency through automated cross-referencing between nonclinical, CMC, and clinical sections

Adapt output depth and detail automatically based on clinical trial phase requirements

Questions

Does CaseMark generate a submission-ready IND application?

CaseMark produces a comprehensive draft structured per 21 CFR 312.23(a) requirements, including all major sections. While the output provides a strong foundation, regulatory professionals should review and finalize the application before FDA submission.

Can CaseMark handle IND applications for different clinical 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-appropriate requirements are reflected throughout the drafted application.

What types of source documents do I need to upload?

At minimum, you should upload nonclinical study reports, CMC data packages, and clinical protocol documents. CaseMark can also incorporate investigator CVs, IRB documentation, prior human experience data, and Form FDA 1572 information for a more complete submission.

Can CaseMark draft IND amendments and pre-IND packages?

Absolutely. CaseMark supports drafting initial IND applications, IND amendments, pre-IND meeting packages, and clinical trial authorization documents. Simply upload the relevant source materials and specify the submission type.

How does CaseMark handle cross-referencing between IND sections?

CaseMark automatically cross-references nonclinical citations, CMC data, and clinical protocol elements across the appropriate IND sections. This ensures internal consistency and proper regulatory linkage throughout the application.

Is my proprietary drug data secure when using CaseMark?

CaseMark employs enterprise-grade encryption and strict data isolation protocols. Your proprietary drug substance information, manufacturing data, and clinical protocols are never shared or used to train models. CaseMark is built for the security requirements of regulated industries.

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