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New Drug Application (NDA)

Draft FDA New Drug Applications in Minutes

45 minutes with CaseMark

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Upload your documents and get a finished work product in minutes. New accounts get $5 free to run their first skill.

45 minutes with CaseMark

What you'll need

  • Clinical Trial Data and Study Reports
  • Chemistry, Manufacturing, and Controls (CMC) Documentation
  • Nonclinical Study Reports
  • Pharmacokinetic and Bioavailability Data

SOC 2 Type II · HIPAA compliant · $5 free credit

Workflow

Overview

Preparing an NDA manually requires coordinating massive volumes of clinical, nonclinical, and manufacturing data across multiple teams—often taking weeks of document compilation, formatting, and cross-referencing against evolving FDA guidelines. Regulatory attorneys and consultants spend 20-30 hours per application ensuring every section meets CFR Part 314 requirements while maintaining consistency across hundreds of pages.

Preparing a New Drug Application requires synthesizing hundreds of clinical, nonclinical, and manufacturing documents into a comprehensive regulatory submission that complies with complex FDA requirements under 21 CFR Part 314. Regulatory teams spend months manually organizing data, drafting technical sections, ensuring eCTD formatting compliance, and cross-referencing thousands of pages of supporting documentation.

CaseMark analyzes your clinical trial data, CMC documentation, and nonclinical studies to automatically generate a complete, FDA-compliant NDA draft. The platform organizes content into proper eCTD modules, creates integrated summaries with benefit-risk assessments, drafts compliant labeling, and ensures all regulatory requirements are addressed with proper cross-references and supporting evidence.

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

  • Administrative Information and Cover Letter

  • Comprehensive Summary

  • Chemistry, Manufacturing, and Controls (CMC)

  • Nonclinical Pharmacology and Toxicology

  • Human Pharmacokinetics and Bioavailability

  • Clinical Data

  • Labeling and Patent Information

  • Environmental Assessment

What it handles

  • Administrative Information and Cover Letter

  • Comprehensive Summary

  • Chemistry, Manufacturing, and Controls (CMC)

  • Nonclinical Pharmacology and Toxicology

  • Human Pharmacokinetics and Bioavailability

  • Clinical Data

  • Labeling and Patent Information

  • Environmental Assessment

Required documents

  • Clinical Trial Data and Study Reports

    Phase 1-3 clinical study reports including patient enrollment, efficacy endpoints, statistical analyses, and adverse event data

    .pdf, .docx, .xlsx

  • Chemistry, Manufacturing, and Controls (CMC) Documentation

    Drug substance characterization, manufacturing processes, analytical methods, stability data, and batch records

    .pdf, .docx

  • Nonclinical Study Reports

    Pharmacology, toxicology, carcinogenicity, reproductive toxicology, and safety pharmacology studies

    .pdf, .docx

  • Pharmacokinetic and Bioavailability Data

    ADME studies, population PK analyses, drug-drug interaction studies, and special population data

    .pdf, .xlsx, .docx

Supporting documents

  • Pre-Submission Meeting Minutes

    FDA meeting minutes, special protocol assessments, or breakthrough therapy designation correspondence

    .pdf, .docx

  • Environmental Assessment Data

    Environmental fate studies, concentration calculations, or categorical exclusion justifications

    .pdf, .docx

  • Patent and Exclusivity Information

    Patent numbers, expiration dates, and regulatory exclusivity claims documentation

    .pdf, .docx

  • Risk Evaluation and Mitigation Strategy (REMS)

    Proposed REMS documents if serious risks require additional risk management measures

    .pdf, .docx

Why teams use it

Generate complete 8-section NDAs in 12 minutes from uploaded clinical and manufacturing data

Auto-populate CMC, pharmacology, and clinical sections with intelligent data extraction from source documents

Real-time FDA guidance verification against eCFR Part 314 and current regulatory standards

Maintain consistency across all sections with AI-powered cross-referencing and citation management

Reduce NDA preparation time by 95% while ensuring comprehensive regulatory compliance

Questions

What information do I need to provide to draft an NDA?

You need clinical trial reports with efficacy and safety data, CMC documentation including manufacturing processes and stability studies, nonclinical pharmacology and toxicology reports, and pharmacokinetic analyses. CaseMark extracts relevant data from these documents to populate all required NDA sections. Optional materials like FDA meeting minutes and environmental assessments enhance the application but aren't mandatory to generate a comprehensive draft.

Does the NDA draft comply with eCTD formatting requirements?

Yes, CaseMark automatically organizes content according to eCTD specifications with proper module structure (Module 1 for administrative information, Module 2 for summaries, Module 3 for quality, Module 4 for nonclinical, and Module 5 for clinical). The platform ensures proper cross-referencing between sections and follows current FDA guidance on electronic submissions. You'll receive a draft ready for eCTD compilation and sponsor review.

How does CaseMark handle the integrated benefit-risk assessment?

CaseMark analyzes efficacy data from pivotal trials and safety data across your clinical program to create a comprehensive benefit-risk narrative. The platform synthesizes treatment effects, adverse event profiles, and clinical meaningfulness to demonstrate that benefits outweigh risks for the target population. It follows 21 CFR 314.50(c) requirements and presents data in a format suitable for FDA multi-disciplinary review.

Can CaseMark draft the proposed product labeling?

Yes, CaseMark generates complete Physician Labeling Rule-compliant prescribing information including Highlights, Full Prescribing Information with all required sections, and patient labeling such as Medication Guides. The platform ensures all labeling statements are supported by substantial evidence from your application data and follows the format requirements under 21 CFR 201.56 and 201.57.

What happens if some required data is missing from my documents?

CaseMark identifies gaps in the evidentiary foundation during document review and clearly flags missing information such as incomplete stability data, absent special population studies, or insufficient safety follow-up. This allows you to address deficiencies before finalizing the submission, reducing the risk of FDA refusal-to-file or major deficiency letters. The platform provides specific guidance on what additional data is needed to satisfy regulatory requirements.

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