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
Reviews FDA regulatory submissions for compliance. Covers 510(k), 21 CFR Part 11, and software as a medical device (SaMD) requirements.
by exact.works
Cold chain compliance review analyzing temperature monitoring, documentation, and regulatory requirements for temperature-sensitive shipments.
by exact.works
Food processing facility compliance assessment including HACCP plans, sanitation SOPs, and FDA registration requirements.
by exact.works
FDA Food Traceability Rule (FSMA 204) compliance documentation including Key Data Elements and Critical Tracking Events.
by exact.works
Food Safety Modernization Act compliance audit covering Produce Safety Rule, Preventive Controls, and FSVP requirements.
by exact.works
Monitor regulatory changes across FDA, EMA, and ICH with impact analysis and implementation timeline tracking.
by exact.works
Assess laboratory data integrity against ALCOA+ principles with gap analysis and remediation recommendations.
by exact.works
Review drug labeling against FDA requirements including PLR format, content requirements, and consistency with approved package insert.
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
Comprehensive assessment of electronic records and electronic signatures compliance, gap analysis, and remediation roadmap for FDA 21 CFR Part 11 requirements.
by exact.works
Electronic records compliance assessment with audit trail validation and signature requirements.
by exact.works
FDA premarket cybersecurity requirements assessment for medical devices with SBOM analysis.