Preparing an IND application manually requires coordinating multiple technical documents, ensuring 21 CFR 312 compliance, locating current FDA forms and guidance, and synthesizing complex CMC, toxicology, and clinical protocol data. This process typically consumes 8+ hours of attorney and paralegal time, with high risk of formatting inconsistencies or missing required sections that can delay FDA review.
Preparing an IND application manually requires coordinating multiple technical documents, ensuring 21 CFR 312 compliance, locating current FDA forms and guidance, and synthesizing complex CMC, toxicology, and clinical protocol data. This process typically consumes 8+ hours of attorney and paralegal time, with high risk of formatting inconsistencies or missing required sections that can delay FDA review.
CaseMark automates IND application drafting by intelligently extracting data from your uploaded protocols, CMC documents, and toxicology studies while simultaneously retrieving current FDA forms and regulatory guidance. The AI structures all required sections per 21 CFR 312.23, generates compliant formatting, and produces a submission-ready draft in approximately 12 minutes—reducing preparation time by over 95%.
This workflow is applicable across multiple practice areas and use cases
Healthcare attorneys advising pharmaceutical and biotech clients on clinical trial compliance and drug development regulatory requirements need to prepare and review IND applications as part of broader healthcare regulatory practice.
IND applications are fundamental healthcare regulatory documents that healthcare law practitioners handle when advising life sciences clients on clinical research authorization and FDA compliance matters.
M&A attorneys conducting due diligence on pharmaceutical and biotech acquisitions must review IND applications to evaluate the regulatory status, development pipeline, and compliance history of target companies.
IND applications are key regulatory assets in life sciences M&A transactions, affecting deal valuation and risk assessment during acquisition of drug development companies.
IP licensing attorneys negotiating pharmaceutical technology transfers and drug development licenses need to review IND applications to assess regulatory status and development stage of licensed compounds.
IND applications contain critical information about drug candidates that directly impacts valuation, licensing terms, and milestone payments in pharmaceutical IP licensing transactions.
VC and PE attorneys investing in pharmaceutical startups need to review IND applications during due diligence to assess regulatory progress, development milestones, and investment risk in drug development companies.
IND application status is a critical milestone for biotech investment decisions, directly impacting funding rounds and company valuations in the life sciences venture capital space.
CaseMark's AI is trained on FDA regulations and automatically structures your IND application according to 21 CFR 312.23 requirements. It cross-references current FDA guidance documents and eCFR provisions while drafting, ensuring all mandatory sections are included with proper formatting and content organization.
Yes, CaseMark uses advanced document analysis to extract relevant chemistry, manufacturing, controls, and toxicology data from your uploaded files. The AI identifies key information like drug composition, manufacturing processes, stability data, and nonclinical study results, then organizes them into the appropriate IND sections.
CaseMark automatically retrieves the most current FDA Form 1571 from official FDA sources and populates it with sponsor details, drug name, and phase information you provide. This ensures you're always using the latest form version without manual searching or downloading.
CaseMark reduces IND application drafting from approximately 8 hours to just 12 minutes—a time savings of over 95%. This allows regulatory attorneys and specialists to focus on strategic review and refinement rather than manual document compilation and formatting.
Absolutely. CaseMark maintains consistency across multiple IND applications while customizing each submission based on the specific documents and data you upload. This is particularly valuable for pharmaceutical companies and law firms managing portfolios of investigational drugs.
CaseMark accommodates optional sections like previous human experience by analyzing any prior clinical data you upload. The AI summarizes relevant findings and integrates them appropriately, even searching clinical trial registries for supporting information when needed.
Yes, CaseMark includes environmental assessment sections and references FDA categorical exclusions under 21 CFR 25. The AI helps determine whether your drug qualifies for an exclusion or requires a full environmental impact statement based on the information provided.