What you'll receive
Regulatory submission packages contain hundreds of pages of complex technical, clinical, and legal data that must be distilled for agency reviewers and internal stakeholders. Manually creating comprehensive summaries is time-intensive, requiring regulatory affairs professionals to spend days extracting key information, ensuring accuracy, and formatting documents to meet compliance standards.
Regulatory submission packages contain hundreds of pages of complex technical, clinical, and legal data that must be distilled for agency reviewers and internal stakeholders. Manually creating comprehensive summaries is time-intensive, requiring regulatory affairs professionals to spend days extracting key information, ensuring accuracy, and formatting documents to meet compliance standards.
CaseMark automatically analyzes complete regulatory submission packages and generates professional, structured summaries that highlight critical approval criteria, supporting evidence, and compliance posture. Our AI extracts essential components across pharmaceutical, medical device, environmental, and financial regulatory contexts, delivering review-ready documents in minutes instead of days.
This workflow is applicable across multiple practice areas and use cases
Healthcare facilities and providers need regulatory submission summaries for CMS certifications, state licensing applications, and compliance with healthcare regulatory bodies beyond FDA drug approvals.
Healthcare law practitioners handle regulatory submissions for hospital accreditations, medical facility licenses, and healthcare program certifications that require similar structured summaries of compliance documentation and supporting data.
Environmental compliance requires regulatory submission summaries for EPA permits, environmental impact assessments, and pollution control approvals that mirror FDA submission processes.
Environmental law practitioners regularly prepare complex regulatory submissions to EPA and state agencies requiring the same structured summary approach, with similar technical data, compliance documentation, and agency correspondence requirements.
Energy sector companies must submit detailed regulatory filings to FERC, DOE, and state utility commissions for facility approvals, rate changes, and environmental compliance that require comprehensive summaries.
Energy law involves extensive regulatory submissions for power plant licensing, pipeline approvals, and renewable energy projects that require summarizing technical data, safety studies, and environmental assessments similar to FDA processes.
Import/export compliance requires regulatory submission summaries for customs declarations, trade agreement certifications, and product safety approvals across multiple international regulatory bodies.
International trade involves complex regulatory filings with customs agencies, foreign regulatory authorities, and trade compliance bodies that benefit from automated summary generation of technical specifications, safety data, and compliance documentation.
CaseMark handles diverse regulatory submissions across industries including pharmaceutical NDAs and ANDAs, medical device 510(k) premarket notifications and PMAs, environmental permits and impact assessments, telecommunications infrastructure filings, financial services rate cases, and chemical substance registrations. The platform adapts to the specific regulatory framework and approval criteria relevant to your submission type.
CaseMark extracts and organizes information according to regulatory review priorities, uses precise regulatory terminology, accurately cites applicable statutes and regulations, and structures summaries to mirror agency review processes. The platform identifies key approval criteria, supporting evidence, and compliance gaps while maintaining the transparency and documentation standards expected by regulatory bodies.
Yes, CaseMark analyzes submissions to flag novel aspects, first-in-class designations, areas lacking precedent, potential safety signals, environmental justice considerations, and other elements that may require additional agency scrutiny. The summary highlights how your submission addresses these concerns and identifies any risk mitigation strategies or supplemental data that may strengthen the regulatory case.
CaseMark extracts clinical and statistical data directly from your submission materials with source attribution, preserving numerical accuracy and appropriate context. All data is presented with proper qualifications, confidence intervals, and study limitations as documented in the original materials. The platform does not interpret or embellish results but accurately reflects what is contained in your submission package.
These summaries serve multiple stakeholders including regulatory affairs teams preparing final submission packages, legal counsel assessing compliance posture, quality assurance teams conducting internal reviews, executive leadership making go/no-go decisions, and compliance officers tracking approval processes. The summaries provide appropriate detail for both technical experts and non-specialist executives who need to understand submission status and risk profile.