Kivo

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23 reviews
  • 1 profiles
  • 5 categories
Average star rating
4.9
Serving customers since
2021
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Kivo Reviews

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Verified User in Biotechnology
CB
Verified User in Biotechnology
Small-Business (50 or fewer emp.)
10/25/2026
Validated Reviewer
Verified Current User
Review source: Organic

eCTD-Mirrored Library Makes Multi-Agency Submissions Easy to Navigate

|Kivo
The document library mirrors the eCTD structure, including the regional Module 1 sections for the US, EU, and Canada. Source documents can be filed exactly where a regulatory reviewer would expect to find them, and the same structure works consistently across multiple health authorities. Submissions are organized by agency and application, so even a multi-country program with many parallel filings remains easy to navigate and follow. Entire submission packages can be imported in the same form they were filed, and the submission viewer lets you review a published sequence without having to leave Kivo.
BW
Bill W.
Quality Assurance ManagerSmall-Business (50 or fewer emp.)
09/22/2026
Validated Reviewer
Verified Current User
Review source: Organic

Intuitive, Well-Supported QMS with Fast Responses and Powerful Platform

|Kivo
Easy to use, intuitive, and well supported. The user interface is friendly and simple to navigate, and the full-text search makes finding documents quick and efficient. It’s also easy to create numerous reports to help manage workflow and track status. The Kivo team is amazing and transparent, and they actively encourage feedback to keep their QMS relevant and top-tier. When we generate tickets, their responses are timely and lead to clear resolutions—usually the same day and often within the hour. The platform performs well overall; we use it as a QMS, LMS, and eTMF, and our team appreciates the one-system approach instead of piecing together several different platforms. Many of our suggestions have been implemented and/or queued for exploration and later implementation; their responsiveness to these needs is valuable and reinforces their role as a trusted partner. They use cutting-edge AI features to enhance their product's functionality.
Natalya S.
NS
Natalya S.
Regulatory Project ManagementMid-Market (51-1000 emp.)
08/31/2026
Validated Reviewer
Verified Current User
Review source: Organic

Responsive, Customer-Focused RIM Platform That’s Simple, Scalable, and Flexible

|Kivo
What I like best about Kivo is how responsive and customer-focused the team is. They’re always easy to reach when we have questions or need support, and they genuinely listen to customer feedback and use it to improve the platform. Unlike other RIM systems we’ve used that can be rigid in their approach, Kivo is flexible and continues to evolve based on what customers actually need. The platform itself is simple, scalable, and easy to use, which makes it a great fit for regulatory teams.

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HQ Location:
Portland, US

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What is Kivo?

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. For more information, visit: https://kivo.io/.

Details

Year Founded
2021
Website
kivo.io