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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 eCTD format. This enables pharmaceutical regulatory teams to produce comprehensive NDA drafts in a fraction of the time traditionally required.

Assembling a New Drug Application is one of the most complex and time-intensive tasks in pharmaceutical development, often requiring months of work by large regulatory affairs teams. Manually compiling clinical trial data, CMC documentation, nonclinical reports, and safety analyses into a coherent five-module eCTD structure is error-prone and creates bottlenecks that delay FDA submission timelines.

CaseMark automates the heavy lifting of NDA assembly by intelligently analyzing your source documents and organizing them into a complete eCTD-compliant five-module structure. The AI generates integrated summaries, benefit-risk assessments, and cross-referenced content that maintains consistency across the entire submission, freeing your regulatory team to focus on scientific review and strategic decision-making.

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 sections including integrated safety analyses and benefit-risk assessments

  4. 4. Export the complete eCTD-formatted submission 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 (CMC) Documentation

  • Module 4: Nonclinical Study Reports

  • Module 5: Clinical Study Reports & Safety Analyses

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 strategy drafting aligned with FDA requirements

Required documents

  • Clinical Trial Data

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

    .pdf, .docx, .xlsx

  • 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 study 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, .xlsx

  • 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 with AI-powered document compilation and structuring

Ensure regulatory compliance with automated alignment to 21 CFR Part 314 requirements and eCTD formatting standards

Generate integrated safety and efficacy analyses that synthesize data across your entire clinical development program

Maintain consistency across all five eCTD modules with cross-referenced data and unified regulatory narrative

Questions

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

You should upload clinical trial data (Phase 1–3 protocols, CSRs, statistical analyses), CMC documentation (drug substance characterization, manufacturing records, stability data), nonclinical study reports, PK/bioavailability data, and any regulatory correspondence. CaseMark will organize all inputs into the proper eCTD modules.

Does CaseMark generate a fully eCTD-compliant submission?

CaseMark drafts all five eCTD modules with content structured to meet FDA requirements under 21 CFR Part 314. 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 to produce integrated safety summaries covering adverse events, SAEs, deaths, and safety signals across your entire development program. It also compiles efficacy data with point estimates, confidence intervals, and p-values from pivotal trials into a structured benefit-risk assessment.

Can this handle 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 Module 1 administrative section and weaves the relevant regulatory strategy throughout the submission narrative.

How long does it take to generate an NDA draft?

CaseMark typically generates a comprehensive NDA draft in approximately 15 minutes, depending on the volume of uploaded source documents. This dramatically reduces the weeks or months traditionally required for initial NDA assembly, allowing your team to focus on scientific review and refinement.

Is my proprietary pharmaceutical data secure on CaseMark?

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

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