by exact.works
Reviews FDA regulatory submissions for compliance. Covers 510(k), 21 CFR Part 11, and software as a medical device (SaMD) requirements.
by exact.works
Review Clinical Study Reports for ICH E3 compliance, data consistency, and regulatory submission readiness with detailed QC checklist.
by exact.works
Prepare regulatory submission documents including eCTD modules, pre-submission meeting requests, and response to FDA queries in compliant format.
by exact.works
Real-time due diligence session. Upload target documents, conduct structured Q&A, receive a formatted memo with findings and flagged risks.
by exact.works
Three-agent pipeline that ingests multiple documents, cross-references them for conflicts and gaps, and produces a unified synthesis report with executive summary.
by exact.works
Accepts raw data and prepares structured regulatory filing drafts with required fields populated and human-review flags clearly marked.