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Investigational New Drug (IND) Application

Draft FDA IND Applications in Minutes, Not Days

12 minutes with CaseMark

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2. Upload the files you want analyzed.

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Workflow

Investigational New Drug (IND) Application

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Workflow

Investigational New Drug (IND) Application

Overview

Preparing an IND application manually requires coordinating multiple technical documents, ensuring 21 CFR 312 compliance, locating current FDA forms and guidance, and synthesizing complex CMC, toxicology, and clinical protocol data. This process typically consumes 8+ hours of attorney and paralegal time, with high risk of formatting inconsistencies or missing required sections that can delay FDA review.

Preparing an IND application manually requires coordinating multiple technical documents, ensuring 21 CFR 312 compliance, locating current FDA forms and guidance, and synthesizing complex CMC, toxicology, and clinical protocol data. This process typically consumes 8+ hours of attorney and paralegal time, with high risk of formatting inconsistencies or missing required sections that can delay FDA review.

CaseMark automates IND application drafting by intelligently extracting data from your uploaded protocols, CMC documents, and toxicology studies while simultaneously retrieving current FDA forms and regulatory guidance. The AI structures all required sections per 21 CFR 312.23, generates compliant formatting, and produces a submission-ready draft in approximately 12 minutes—reducing preparation time by over 95%.

How it works

  1. 1. Upload your documents

  2. 2. AI analyzes and extracts key information

  3. 3. Review and customize the generated content

  4. 4. Export in your preferred format (DOCX, PDF)

What you get

  • Cover Sheet (FDA Form 1571)

  • Table of Contents

  • Introductory Statement and General Investigational Plan

  • Investigator's Brochure

  • Clinical Protocols

  • Chemistry, Manufacturing, and Controls (CMC) Information

  • Pharmacology and Toxicology Data

  • Previous Human Experience

  • Environmental Assessment

  • Additional Information

What it handles

  • Cover Sheet (FDA Form 1571)

  • Table of Contents

  • Introductory Statement and General Investigational Plan

  • Investigator's Brochure

  • Clinical Protocols

  • Chemistry, Manufacturing, and Controls (CMC) Information

  • Pharmacology and Toxicology Data

  • Previous Human Experience

  • Environmental Assessment

  • Additional Information

Required documents

  • Clinical Protocols

    Study design documents, objectives, and procedures for planned clinical investigations

    .pdf, .docx

  • Pharmacology and Toxicology Studies

    Nonclinical study results and safety data from preclinical testing

    .pdf, .docx

  • Chemistry, Manufacturing, and Controls (CMC) Data

    Drug composition, manufacturing process documentation, and stability testing results

    .pdf, .docx, .xlsx

Supporting documents

  • Previous Clinical Data

    Prior human experience data from earlier studies or foreign trials, if applicable

    .pdf, .docx

  • Investigator's Brochure

    Existing brochure summarizing drug information for investigators

    .pdf, .docx

  • IRB Approvals

    Institutional Review Board approval letters and supporting documentation

    .pdf

  • Environmental Assessment Data

    Environmental impact information or categorical exclusion justification

    .pdf, .docx

Why teams use it

Generate complete 10-section IND applications in 12 minutes vs. 8+ hours manually

Automatic 21 CFR 312 compliance checking with real-time FDA guidance integration

Intelligent extraction of CMC, toxicology, and protocol data from uploaded documents

Built-in FDA Form 1571 template population with sponsor and drug information

Consistent formatting and section structure that meets FDA eCFR requirements

Questions

How does CaseMark ensure my IND application complies with 21 CFR 312 requirements?

CaseMark's AI is trained on FDA regulations and automatically structures your IND application according to 21 CFR 312.23 requirements. It cross-references current FDA guidance documents and eCFR provisions while drafting, ensuring all mandatory sections are included with proper formatting and content organization.

Can CaseMark extract technical data from my existing CMC and toxicology documents?

Yes, CaseMark uses advanced document analysis to extract relevant chemistry, manufacturing, controls, and toxicology data from your uploaded files. The AI identifies key information like drug composition, manufacturing processes, stability data, and nonclinical study results, then organizes them into the appropriate IND sections.

Does CaseMark include the current FDA Form 1571 in the application?

CaseMark automatically retrieves the most current FDA Form 1571 from official FDA sources and populates it with sponsor details, drug name, and phase information you provide. This ensures you're always using the latest form version without manual searching or downloading.

How much time can I save using CaseMark for IND application preparation?

CaseMark reduces IND application drafting from approximately 8 hours to just 12 minutes—a time savings of over 95%. This allows regulatory attorneys and specialists to focus on strategic review and refinement rather than manual document compilation and formatting.

Can CaseMark help with multiple IND applications for different drug candidates?

Absolutely. CaseMark maintains consistency across multiple IND applications while customizing each submission based on the specific documents and data you upload. This is particularly valuable for pharmaceutical companies and law firms managing portfolios of investigational drugs.

What if I need to include previous human experience data in my IND?

CaseMark accommodates optional sections like previous human experience by analyzing any prior clinical data you upload. The AI summarizes relevant findings and integrates them appropriately, even searching clinical trial registries for supporting information when needed.

Does CaseMark handle environmental assessment requirements for IND applications?

Yes, CaseMark includes environmental assessment sections and references FDA categorical exclusions under 21 CFR 25. The AI helps determine whether your drug qualifies for an exclusion or requires a full environmental impact statement based on the information provided.

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