Navigate FDA NDA submissions, clinical study reports, and IND applications with AI that cites every finding to its exact source page — meeting the traceability requirements that regulatory affairs demands.
500,000+
pages per NDA submission
in a typical FDA New Drug Application — requiring regulatory affairs teams to cross-reference modules, clinical study reports, and preclinical data across years of research
80%
of RA team time
spent on document review and cross-referencing rather than regulatory strategy — making AI-assisted review a direct multiplier on submission quality
$2.6B
average drug development cost
makes documentation errors and submission delays among the most expensive problems in pharmaceutical development
Analyze 510(k) submissions, IND applications, and NDA modules. Ask questions across all CTD sections and receive cited answers tracing to the exact module and page.
Extract primary and secondary endpoints, adverse event profiles, statistical results, and protocol deviations from CSRs of any length with page-level citations.
Upload regulatory guidance documents, agency letters, and inspection reports. Cross-reference against your submission documents to identify gaps before the agency does.
Every AI answer includes the source document, module, and page citation — providing the traceability documentation required in GxP-regulated workflows.
7-day free Pro trial — no credit card required. Upload your first document in under a minute.