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
Analyze change control records for compliance, impact assessment completeness, and regulatory notification requirements.
by exact.works
Assess laboratory data integrity against ALCOA+ principles with gap analysis and remediation recommendations.
by exact.works
Generate IQ/OQ/PQ documentation for pharmaceutical manufacturing equipment with test protocols and acceptance criteria.
by exact.works
Analyze environmental monitoring data for cleanroom compliance, trend identification, and excursion investigation support.
by exact.works
Analyze bioequivalence study data including statistical analysis, confidence interval calculations, and BE criteria assessment.
by exact.works
Review and optimize clinical trial protocols for feasibility, regulatory compliance, and operational efficiency.
by exact.works
Analyze clinical trial protocol deviations for trending, root cause patterns, and impact assessment on data integrity.
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
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.