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.
This workflow is applicable across multiple practice areas and use cases
Healthcare attorneys advising hospitals, pharmacies, and healthcare systems need NDA documentation to ensure compliance with drug formulary requirements and reimbursement regulations.
Healthcare law practitioners regularly review FDA approval documentation to advise on drug coverage policies, Medicare/Medicaid reimbursement, and institutional drug procurement compliance.
Pharmaceutical M&A transactions require comprehensive NDA documentation review for due diligence on drug pipeline assets and regulatory approval status.
Acquirers need to assess the regulatory compliance and approval status of drug candidates, making NDA preparation and review critical for valuation and deal structuring in pharma acquisitions.
Drug licensing agreements require detailed NDA documentation to establish the regulatory status, clinical data, and commercial viability of licensed pharmaceutical products.
Licensors and licensees need comprehensive NDA information to negotiate milestone payments, royalties, and territorial rights based on regulatory approval status and market exclusivity.
VC and PE firms investing in biotech and pharmaceutical companies require NDA documentation analysis for investment due diligence and portfolio company valuation.
Investors need to assess regulatory risk, development timelines, and commercial potential of drug candidates through NDA status review before making investment decisions in life sciences companies.
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.
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.
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.
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.
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.