Kivo Information

Kivo is building the infrastructure for GxP compliance in the era of AI-powered drug development. Its unified cloud platform supports Regulatory, Clinical, and Quality operations — including RIM, eTMF, QMS, controlled document management, submission assembly, eCTD lifecycle management, inspection readiness, SOP management, and training management — within a single, audit-ready environment. With Part 11-compliant e-signatures, role-based permissions, continuous validation assurance, and a lossless data model that preserves context from legacy systems, Kivo gives life sciences teams the compliant foundation to reduce operational friction and accelerate time to market. Clinical Capabilities: eTMF - Electronic Trial Master File TMF Transfer & Migration Trial Archiving / Long Term Storage Active CRO Trial Management Vendor Management Inspection Preparedness & Readiness Regulatory Capabilities: RIM - Regulatory Information Management eCTD - Electronic Common Technical Document Submission Assembly Document Templates Project Management Registration Management Dossier Management Quality Capabilities: QMS - Quality Management System CAPA Management Vendor Audit SOP Management Training