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.
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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
