About
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
Details
- Tagline:
- The GxP Compliant, agent-native platform for Regulatory, Clinical, and Quality operations. Makers of Headless GxP
- Industry:
- Software Development
- Company size:
- 11-50
- Headquarters:
- Portland
- Oregon
- Org type:
- Privately Held
- Founded:
- 2021
- Specialties:
- Regulatory, Clinical, Quality, Regulatory Submissions, eCTD Templates, Clinical Operations, Regulatory Operations, CAPA Management, TMF Management, Trial Master File, Drug Development, QMS, RIM, eTMF, Document Management, GxP Compliance, AI Native, and Validation
- Follower count:
- 1849
- Employee count:
- 47
