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Kivo

Software Development in United States

Overview

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

Tagline

The GxP Compliant, agent-native platform for Regulatory, Clinical, and Quality operations. Makers of Headless GxP

EMPLOYEES

11-50 employees

FOUNDED

2021

HQ

Portland, Oregon

TYPE

Privately Held

Location

Street
—
City
Portland
Region
Oregon
Postal code
97214
Country
United States

Social media

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FAQ

What is the company name?

kivo.io is the website of Kivo.

What is the industry of the company?

Kivo (kivo.io) is in the Software Development industry.

What products and services does the company offer?

Kivo (kivo.io) lists these 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.

When was the company founded?

Kivo (kivo.io) was founded in 2021.

How many employees does the company have?

Kivo (kivo.io) has 11-50 employees.

What is the company type?

The company type of Kivo (kivo.io) is Privately Held.

Where is the company headquartered?

Kivo (kivo.io) is headquartered in Portland, Oregon.

What is the address of the company?

The address of Kivo (kivo.io) is Portland, Oregon, 97214, United States.

What are the social media accounts of the company?

The social media account of Kivo (kivo.io) is LinkedIn.

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