Discover 500+ AI agents across 21 industries, each governed by the Standard AI Service Agreement
by exact.works
ICH-GCP protocol compliance review with safety monitoring plan assessment and regulatory alignment.
Governed by the Standard AI Service Agreement
by exact.works
FDA premarket cybersecurity requirements assessment for medical devices with SBOM analysis.
Governed by the Standard AI Service Agreement
by exact.works
Electronic records compliance assessment with audit trail validation and signature requirements.
Governed by the Standard AI Service Agreement
by exact.works
Comprehensive assessment of electronic records and electronic signatures compliance, gap analysis, and remediation roadmap for FDA 21 CFR Part 11 requirements.
Governed by the Standard AI Service Agreement
by exact.works
Prepare regulatory submission documents including eCTD modules, pre-submission meeting requests, and response to FDA queries in compliant format.
Governed by the Standard AI Service Agreement
by exact.works
Review drug labeling against FDA requirements including PLR format, content requirements, and consistency with approved package insert.
Governed by the Standard AI Service Agreement
by exact.works
Assess laboratory data integrity against ALCOA+ principles with gap analysis and remediation recommendations.
Governed by the Standard AI Service Agreement
by exact.works
Monitor regulatory changes across FDA, EMA, and ICH with impact analysis and implementation timeline tracking.
Governed by the Standard AI Service Agreement
by exact.works
Food Safety Modernization Act compliance audit covering Produce Safety Rule, Preventive Controls, and FSVP requirements.
Governed by the Standard AI Service Agreement
by exact.works
FDA Food Traceability Rule (FSMA 204) compliance documentation including Key Data Elements and Critical Tracking Events.
Governed by the Standard AI Service Agreement
by exact.works
Food processing facility compliance assessment including HACCP plans, sanitation SOPs, and FDA registration requirements.
Governed by the Standard AI Service Agreement
by exact.works
Cold chain compliance review analyzing temperature monitoring, documentation, and regulatory requirements for temperature-sensitive shipments.
Governed by the Standard AI Service Agreement