What Kivo does

Kivo is a private, Delaware-incorporated SaaS company headquartered in Portland, Oregon, founded in 2021 to deliver cloud-based document and process management for life sciences organizations. The platform unifies four core modules — Document Management System (DMS), Regulatory Information Management (RIM), electronic Trial Master File (eTMF), and Quality Management System (QMS) — under a single all-inclusive subscription priced from $1,800 per month, with no per-module fees. Built on the EDM Reference Model and aligned to 21 CFR Part 11, EU Annex 11, GxP, GCP, ICH, SOC 2 Type 2, ISO 9001, and ISO 27001, Kivo combines lifetime validation with each release, Microsoft Office Online collaborative editing, embedded DocuSign Part-11 e-signatures (and, as of April 2026, native Part 11 e-signatures), an eCTD 4.0 viewer, a Submission Builder, and more than 450 ICH document templates.

The company serves more than 100 sponsors and service providers across the U.S., Europe, and Asia, managing over 100 active drug applications to the FDA, EMA, MHRA, and Health Canada. Customers span mid-market biotech (Elevar, Ventus, Fulcrum, Astria, Morphic Therapeutics, HDT Bio, Artiva, Azura, Durect, STAR Therapeutics, Trevi, Arbor Biotech), enterprise CROs (Labcorp), and life sciences consultants. Kivo sells through direct enterprise sales with demo-driven engagement, targeting teams that have been underserved by legacy RIM and QMS platforms that cost 10x more and take 6-12 months to implement versus Kivo's typical two-week onboarding. Revenue is generated through SaaS subscription contracts that bundle implementation, validation, training, and support.

Kivo has raised approximately $11.2 million across a 2022 seed round co-led by Facet Life Sciences and Oregon Venture Fund, a 2024 follow-on, and a December 2025 SEC Form D filing of roughly $5.1 million. The company maintains a lean team of 1-10 employees and operates Headless GxP, an architectural initiative positioning the platform as a compliant system of record that any tool, model, or agentic workflow can integrate with via MCP. Operations continue with a steady quarterly release cadence from 2022 through 2026.Q2.

Name

Kivo

Legal name

Kivo, Inc.

Website

https://kivo.io

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

Kivo is a Portland-based SaaS provider of unified document, regulatory, trial master file, and quality management software for life sciences companies. Its all-inclusive platform offers Part 11 compliant e-signatures, lifetime validation, and Headless GxP architecture for agentic AI workflows.

Ownership category

akta.pro rank

Product category

Life Sciences Regulatory Software

NAICS

Software Publishers (5132)

SIC

Services-Computer Programming, Data Processing, Etc. (7370), Services-Computer Programming Services (7371)

akta.pro primary industry

Electronic Lab Notebooks (ELN) (HLAGAJAB)

Keywords

• Regulatory information management
• Clinical document management
• Trial master file software
• Life sciences quality management
• Pharma regulatory submissions

Headquarters

HQ city

Portland

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure

Revenue model

1. SaaS Subscription: Kivo operates as a Software-as-a-Service (SaaS) company charging subscription fees for access to their platform. The subscription includes all modules (DMS, RIM, eTMF, QMS) with additional modules able to be turned on at any time. Implementation, setup, maintenance, continuous validation, training, and support are included in the subscription price.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Kivo provides an all-in-one cloud-based document and process management SaaS platform for life sciences organizations. The platform unifies Document Management System (DMS), Regulatory Information Management (RIM), electronic Trial Master File (eTMF), and Quality Management System (QMS) capabilities, with native 21 CFR Part 11 compliance and add-on modules for regulatory submissions, training, and correspondence.

Product overview

Kivo is an all-in-one, SaaS-based document and process management platform designed specifically for life sciences organizations. The platform operates as a unified system with four core integrated modules: DMS (Document Management System) for controlled document management with Part-11 compliant e-signatures, RIM (Regulatory Information Management) for regulatory submissions and lifecycle management, eTMF (electronic Trial Master File) for clinical trial document management, and QMS (Quality Management System) for quality oversight and compliance. All modules are included in the subscription with no per-module pricing. The platform also offers Headless GxP as a modern architecture initiative for agentic AI workflows, plus specialized add-on capabilities including an eCTD Viewer, Submission Builder, over 450 ICH Document Templates, Training Management, and Correspondence Management. The platform is browser-based, requires no IT deployment, and supports both PC and Mac environments.

Differentiator

Problem solved

Functional benefit

Products and services

• Document Management System (DMS)
• Regulatory Information Management (RIM)
• Electronic Trial Master File (eTMF)
• Quality Management System (QMS)
• Headless GxP
• eCTD Viewer
• Submission Builder
• ICH Document Templates
• Training Management
• Correspondence Management

Quantifiable outcome

• Validation time reduced by 80-90%
• +3 more outcomes

Named customers19 records

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

AI capability3 records

Feature7 records

Partnerships

Four partnerships are on record, tiered core and minor.

• DocuSigncoreTechnology or IntegrationDocuSign integration provides Part 11 compliant electronic signatures embedded directly in the Kivo platform. Kivo includes DocuSign licenses with no separate license required, enabling compliant e-signatures for document approvals.
• MicrosoftcoreTechnology or IntegrationDeep integration with Microsoft Office Online for real-time collaborative editing of documents directly in the browser. Also supports Microsoft Office 365 for local editing.
• EDM Reference Model / GxP StandardscoreTechnology or IntegrationKivo is built on the Electronic Document Management (EDM) Reference Model and GxP Standards, ensuring alignment with industry compliance requirements.
• Publishing Vendors (e.g., Docubridge)minorChannel Partner/ Reseller/ DistributorKivo partners with external publishing vendors that customers use for final eCTD publishing. Kivo's platform supports easy publishing exports and eCTD re-import for seamless handoff to preferred publishers.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Qualio: Qualio offers a cloud QMS with document and training management aimed at life sciences, sharing Kivo's focus on emerging and mid-market sponsors and intuitive UX.
• Veeva Systems: Veeva's Vault platform is the dominant RIM, QMS, eTMF, and document management suite for life sciences. It competes directly with Kivo across every core module, but is built for large pharma with enterprise pricing and longer implementations.
• ComplianceQuest: ComplianceQuest delivers a Salesforce-native QMS, document, and training management platform for life sciences and manufacturing, competing with Kivo's QMS and document automation capabilities.
• MasterControl: MasterControl provides QMS, document control, and compliance software for life sciences manufacturers and is one of the legacy players Kivo explicitly positions against on cost and ease of use.
• Greenlight Guru: Greenlight Guru provides QMS and document control purpose-built for medical device companies, overlapping with Kivo's life sciences QMS and DMS capabilities in the regulated-document workflow space.
• Dot Compliance: Dot Compliance provides AI-enabled QMS and regulatory document management for life sciences, overlapping with Kivo's QMS and RIM modules, especially for mid-sized sponsors.
• PTC Arena: PTC's Arena solution offers PLM, quality, and document management for life sciences and medical devices, competing with Kivo's DMS and QMS in regulated document and change-control workflows.

Others

• Box: Box is a general-purpose content management platform with regulated-industry capabilities that some life sciences teams use alongside or as an alternative to Kivo's DMS module for controlled documents.
• DocuSign: DocuSign is both a Kivo integration partner for Part 11 e-signatures and a broader workflow/e-signature provider that overlaps with Kivo's document approval capabilities in adjacent use cases.

Broad incumbents

• Medidata Solutions (Dassault Systèmes): Medidata provides clinical trial platforms (Rave, eTMF) within the broader Dassault 3DEXPERIENCE life sciences stack. It overlaps with Kivo's eTMF module as a much larger incumbent in clinical operations.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/kivoio

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds3 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Kivo