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
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.
by exact.works
Develop comprehensive validation protocols for GxP computerized systems including IQ/OQ/PQ planning, risk assessment, and traceability matrices.
by exact.works
Comprehensive assessment of electronic records and electronic signatures compliance, gap analysis, and remediation roadmap for FDA 21 CFR Part 11 requirements.
by exact.works
Assess building envelope design and performance including air barriers, vapor retarders, and thermal performance.
by exact.works
Analyze contract bonding requirements and verify compliance with performance, payment, and bid bond obligations.
by exact.works
TPA compliance review, service agreement validation, and performance monitoring.