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Ind Application

Draft FDA IND Applications in Minutes, Not Hours

15 minutes with CaseMark

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15 minutes with CaseMark

What you'll need

  • Nonclinical Study Reports
  • CMC Documentation
  • Clinical Protocol(s)

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Workflow

Overview

CaseMark's IND Application Drafter uses AI to transform your nonclinical data, CMC documentation, and clinical protocols into a complete Investigational New Drug application structured under 21 CFR Part 312. The tool generates every major section—from Form 1571 through pharmacology/toxicology summaries—so your regulatory team can focus on scientific review rather than document assembly. It supports original IND submissions, pre-IND packages, amendments, and multi-phase clinical programs.

Preparing an IND application is one of the most document-intensive tasks in pharmaceutical development. Regulatory teams spend weeks manually organizing nonclinical reports, CMC data, and clinical protocols into the precise section structure required by 21 CFR Part 312, with constant risk of omissions, inconsistent cross-references, and formatting errors that can delay FDA review.

CaseMark automates the structural drafting of IND applications by ingesting your source documents and producing a complete, properly ordered submission package under 21 CFR 312.23(a). Built-in compliance checklists and automatic cross-referencing ensure nothing is missed, letting your regulatory team focus on the science and strategy behind the submission rather than the mechanics of document assembly.

How it works

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

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

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

  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(s)

  • CMC: Drug Substance & Drug Product

  • Pharmacology & Toxicology Summary

  • Previous Human Experience

  • Environmental Assessment & Compliance Checklists

What it handles

  • Generates complete IND structure following 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

  • Builds CMC sections for drug substance and drug product with specs and stability data

  • Creates clinical protocol drafts with study design, endpoints, and statistical analysis plans

  • Cross-references nonclinical citations to specific IND sections automatically

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 drug product

    .pdf, .docx

  • Clinical Protocol(s)

    Study design documents including objectives, endpoints, dosing, safety monitoring, and statistical analysis plans

    .pdf, .docx

Supporting documents

  • Investigator CVs and Form 1572

    Curriculum vitae and signed Form FDA 1572 for each clinical investigator

    .pdf, .docx

  • Prior Human Experience Data

    Foreign clinical trial reports, published literature, or compassionate use data for the investigational drug

    .pdf, .docx

  • IRB Documentation

    Institutional Review Board approval letters, submission plans, and informed consent form templates

    .pdf, .docx

  • Pre-IND Meeting Minutes

    FDA meeting minutes or correspondence from pre-IND interactions that may inform submission strategy

    .pdf, .docx

Why teams use it

Reduce IND drafting time from weeks to hours by automating document structure and cross-referencing

Ensure regulatory completeness with built-in checklists aligned to 21 CFR 312.23(a) requirements

Maintain consistent formatting and terminology across all IND sections and amendments

Free regulatory affairs professionals to focus on scientific strategy rather than document assembly

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 drug product, pharmacology/toxicology summaries, and previous human experience. Each section follows FDA regulatory numbering conventions.

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 I applications receive appropriately scaled CMC and toxicology content, while later-phase submissions include more comprehensive data packages.

Does CaseMark replace the need for regulatory affairs professionals?

No. CaseMark accelerates the drafting process by organizing your source data into a structured IND format, but all output should be reviewed and finalized by qualified regulatory affairs professionals and legal counsel 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 the specific submission type you need.

How does CaseMark ensure compliance with 21 CFR Part 312?

CaseMark structures every output section according to the regulatory requirements of 21 CFR 312.23(a) and includes built-in checklists for Form 1571, Investigator's Brochure completeness, protocol elements, and environmental assessment requirements to help ensure nothing is missed.

What file formats can I upload and export?

CaseMark accepts PDF, DOCX, and common document formats for your source materials. Completed IND application drafts can be exported as DOCX or PDF files, ready for internal review or regulatory submission preparation.

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