by exact.works
Verify compliance consistency across retail channels including online, mobile, in-store, and marketplace presence.
by exact.works
Monitor regulatory changes across FDA, EMA, and ICH with impact analysis and implementation timeline tracking.
by exact.works
Conduct quality risk assessments per ICH Q9 using FMEA, FTA, or HACCP methodologies with risk ranking and mitigation strategies.
by exact.works
Analyze ICH stability data including trending, shelf-life estimation, and out-of-specification investigation support.
by exact.works
Review Clinical Study Reports for ICH E3 compliance, data consistency, and regulatory submission readiness with detailed QC checklist.
by exact.works
ICH-GCP protocol compliance review with safety monitoring plan assessment and regulatory alignment.
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.