Nda Drug Application

Draft eCTD-Compliant NDA Submissions in Minutes

15 minutes with CaseMark

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15 minutes with CaseMark

What you'll need

Clinical Trial Data
CMC Documentation
Nonclinical Study Reports

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

Workflow

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, pharmacokinetics, and proposed labeling into a structured five-module eCTD format. The result is a comprehensive, submission-ready NDA draft that dramatically reduces the time and effort required for regulatory filing.

Preparing a New Drug Application is one of the most complex and time-intensive tasks in pharmaceutical development, often requiring months of manual compilation across clinical, nonclinical, and manufacturing datasets. Regulatory teams must cross-reference thousands of pages of study reports, ensure eCTD structural compliance, and synthesize integrated summaries—all while meeting strict FDA formatting and content requirements. Errors or inconsistencies can delay approval timelines and cost millions in lost market exclusivity.

CaseMark automates the heavy lifting of NDA assembly by ingesting your clinical trial data, CMC documentation, nonclinical reports, and regulatory correspondence, then organizing everything into a properly structured five-module eCTD format. The AI generates integrated summaries, benefit-risk assessments, and cross-referenced content that your regulatory team can review and refine, transforming a months-long process into a streamlined workflow that accelerates your path to FDA approval.

How it works

1. Upload clinical trial data, CMC documentation, nonclinical reports, and regulatory correspondence
2. AI analyzes and organizes all source data into the five-module eCTD structure per 21 CFR Part 314
3. Review integrated summaries, benefit-risk assessments, and proposed labeling for accuracy
4. Export the complete NDA draft in your preferred format (DOCX, PDF) ready for FDA submission

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, safety signals, and efficacy endpoints
CMC quality documentation including drug substance characterization, manufacturing processes, and stability data
Nonclinical study compilation covering pharmacology, toxicology, and safety pharmacology reports
PK/bioavailability integration with DDI studies, exposure-response analyses, and special population data
Proposed labeling and REMS strategy drafting aligned with FDA guidance

Required documents

Clinical Trial Data
Phase 1–3 protocols, clinical study reports, statistical analyses, and patient demographics
.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 reports
.pdf, .docx

Supporting documents

PK and Bioavailability Data
Human pharmacokinetic studies, drug-drug interaction studies, exposure-response analyses, and special population 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 preparation time from weeks to hours by automating document compilation and cross-referencing across all five eCTD modules

Ensure structural compliance with 21 CFR Part 314 and current FDA eCTD guidance through built-in regulatory formatting

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

Maintain consistency across modules with automated cross-referencing of clinical endpoints, safety signals, and CMC specifications

Questions

Does CaseMark generate a fully eCTD-compliant NDA?

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

What types of clinical data can I upload?

CaseMark accepts Phase 1–3 protocols, clinical study reports (CSRs), statistical analysis plans and outputs, patient demographics, and integrated safety datasets. You can upload these as PDF, DOCX, or other standard document formats.

How does the AI handle the integrated benefit-risk assessment?

CaseMark analyzes your pivotal trial results—including point estimates, confidence intervals, and p-values—alongside the integrated safety profile across your development program. It synthesizes this into a structured benefit-risk assessment weighing efficacy magnitude against adverse event frequency and severity, per FDA guidance.

Can CaseMark incorporate prior FDA correspondence and meeting minutes?

Yes. Upload pre-IND meeting minutes, pre-NDA meeting feedback, special protocol assessments, and any other FDA correspondence. CaseMark references these throughout the NDA to demonstrate regulatory alignment and address prior agency feedback.

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 source documents. This replaces weeks of manual compilation and cross-referencing, allowing your regulatory team to focus on scientific review and strategic refinement.

Is my proprietary pharmaceutical data secure on CaseMark?

CaseMark employs enterprise-grade encryption and strict data isolation protocols. Your clinical trial data, CMC documentation, and trade secrets are never shared across accounts or used to train models, ensuring full confidentiality of your proprietary information.