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.
by exact.works
Review and optimize clinical trial protocols for feasibility, regulatory compliance, and operational efficiency.
by exact.works
Prepare supplier qualification documentation including questionnaires, audit checklists, and quality agreement templates.
by exact.works
Analyze clinical trial protocol deviations for trending, root cause patterns, and impact assessment on data integrity.
by exact.works
Analyze ICH stability data including trending, shelf-life estimation, and out-of-specification investigation support.
by exact.works
Review batch production records for GMP compliance, data integrity, and completeness with deviation flagging.
by exact.works
Document and analyze Corrective and Preventive Actions including root cause analysis, effectiveness criteria, and trending reports.
by exact.works
Review drug labeling against FDA requirements including PLR format, content requirements, and consistency with approved package insert.
by exact.works
Prepare for GMP regulatory inspections with gap assessment, mock audit protocols, and response template development.
by exact.works
Review Clinical Study Reports for ICH E3 compliance, data consistency, and regulatory submission readiness with detailed QC checklist.
by exact.works
Generate Chemistry, Manufacturing, and Controls documentation including drug substance specs, manufacturing process descriptions, and analytical methods.
by exact.works
Analyze adverse event databases for safety signals using statistical methods including PRR, ROR, and EBGM with trend visualization.
by exact.works
Prepare regulatory submission documents including eCTD modules, pre-submission meeting requests, and response to FDA queries in compliant format.