by exact.works
Generate complete Production Part Approval Process documentation packages including all 18 elements for automotive supplier submissions.
by exact.works
Monitor regulatory changes across FDA, EMA, and ICH with impact analysis and implementation timeline tracking.
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
Document process validation lifecycle including process design, qualification protocols, and continued process verification.
by exact.works
Generate regulatory safety reports including CIOMS forms, MedWatch reports, and periodic safety update reports.
by exact.works
Review and optimize clinical trial protocols for feasibility, regulatory compliance, and operational efficiency.
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
Prepare regulatory submission documents including eCTD modules, pre-submission meeting requests, and response to FDA queries in compliant format.
by exact.works
Generate comprehensive punch lists from inspection reports with categorization by trade and priority.
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.