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Nda Drug Application

Draft eCTD-Compliant NDA Submissions in Minutes

15 minutes with CaseMark

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Workflow

Nda Drug Application

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Workflow

Nda Drug Application

Overview

CaseMark's NDA Drug Application skill automates the drafting of eCTD-compliant New Drug Applications for FDA submission under 21 CFR Part 314. It compiles clinical trial data, CMC documentation, nonclinical studies, pharmacokinetic analyses, and proposed labeling into a structured five-module submission package. This dramatically accelerates the most document-intensive phase of bringing a new molecular entity to market.

Assembling a New Drug Application is one of the most complex and time-consuming tasks in pharmaceutical development, often requiring months of effort from large regulatory affairs teams to compile thousands of pages across five eCTD modules. Manual assembly risks inconsistencies between modules, gaps in cross-referencing, and formatting errors that can lead to FDA refuse-to-file decisions or costly review delays.

CaseMark's AI-powered NDA drafting skill ingests your clinical, nonclinical, CMC, and regulatory source documents and automatically organizes them into a complete five-module eCTD structure with integrated summaries and benefit-risk analyses. This gives regulatory affairs teams a comprehensive first draft in minutes, allowing them to focus their expertise on scientific review, strategic positioning, and ensuring the strongest possible submission.

How it works

  1. 1. Upload clinical trial data, CMC documentation, nonclinical reports, and regulatory correspondence

  2. 2. AI analyzes and organizes all source data into the five-module eCTD structure per 21 CFR Part 314

  3. 3. Review the drafted NDA including integrated summaries, benefit-risk assessments, and proposed labeling

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

What you get

  • Module 1: Administrative Information & Regulatory Strategy

  • Module 2: Integrated Summaries & Benefit-Risk Assessment

  • Module 3: Quality Overall Summary & CMC Data

  • Module 4: Nonclinical Study Reports & Tabulated Summaries

  • Module 5: Clinical Study Reports & Integrated Safety Analysis

What it handles

  • Five-module eCTD structure assembly with administrative, summary, quality, nonclinical, and clinical modules

  • Integrated benefit-risk analysis with pivotal trial summaries, point estimates, and confidence intervals

  • CMC quality documentation including drug substance characterization, manufacturing process, and stability data

  • Comprehensive nonclinical study compilation covering pharmacology, toxicology, and safety pharmacology

  • Pharmacokinetic and bioavailability data integration with DDI studies and exposure-response analyses

  • Proposed labeling and REMS drafting aligned with FDA Form 356h requirements

Required documents

  • Clinical Trial Data

    Phase 1–3 protocols, clinical study reports (CSRs), statistical analyses, and patient demographics

    .pdf, .docx

  • CMC Documentation

    Drug substance characterization, manufacturing process descriptions, batch records, and stability data

    .pdf, .docx

  • Nonclinical Study Reports

    Pharmacology, toxicology (general, genetic, reproductive, carcinogenicity), and safety pharmacology reports

    .pdf, .docx

Supporting documents

  • PK and Bioavailability Data

    Human pharmacokinetic studies, special population analyses, drug-drug interaction studies, and exposure-response data

    .pdf, .docx

  • Regulatory Correspondence

    Pre-IND and pre-NDA meeting minutes, special protocol assessments, and FDA feedback letters

    .pdf, .docx

  • Proposed Labeling Drafts

    Draft prescribing information, patient labeling, and medication guides

    .pdf, .docx

  • Patent and Exclusivity Information

    Patent numbers, expiration dates, and exclusivity claims for Orange Book listing

    .pdf, .docx

Why teams use it

Reduce NDA assembly time from weeks to minutes by automating document compilation and eCTD structuring across all five modules

Ensure regulatory compliance with 21 CFR Part 314 requirements through AI-guided structure and content organization

Generate integrated benefit-risk assessments that synthesize safety and efficacy data across your entire clinical development program

Minimize costly submission deficiencies by producing comprehensive, well-organized drafts that align with FDA expectations

Questions

What types of documents do I need to upload for NDA drafting?

CaseMark requires your clinical trial data (Phase 1–3 protocols, CSRs, statistical analyses), CMC documentation (drug substance characterization, manufacturing process, stability data), and nonclinical study reports at minimum. Regulatory correspondence, PK data, and proposed labeling drafts improve output quality significantly.

Does CaseMark generate a fully eCTD-compliant submission?

CaseMark drafts all five eCTD modules with proper structure and content organization aligned with 21 CFR Part 314 requirements. The output provides a comprehensive draft that your regulatory team can review, refine, and finalize before electronic submission through the FDA gateway.

How does the AI handle integrated safety and efficacy analyses?

CaseMark analyzes your clinical trial data across the entire development program to generate integrated safety summaries including adverse event profiles, SAEs, deaths, and safety signals. It also compiles efficacy data with point estimates, confidence intervals, and p-values from pivotal trials for the benefit-risk assessment.

Can CaseMark accommodate special regulatory designations like breakthrough therapy or fast track?

Yes. CaseMark incorporates special designations including breakthrough therapy, fast track, priority review, and orphan drug status into the administrative module and regulatory strategy narrative. Simply include your FDA correspondence documenting these designations in your uploaded materials.

How long does it take to generate an NDA draft?

CaseMark typically generates a comprehensive NDA draft in approximately 15 minutes, compared to the weeks or months traditionally required for manual assembly. This allows your regulatory affairs team to focus on scientific review and strategic refinement rather than document compilation.

Is my proprietary pharmaceutical data secure on CaseMark?

CaseMark employs enterprise-grade encryption and security protocols to protect all uploaded documents and generated content. Your proprietary clinical data, CMC information, and trade secrets remain confidential and are never used to train models or shared with third parties.

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