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What is Kivo?

Kivo presents a groundbreaking solution tailored for sponsors and CROs by offering an affordable document and process management platform that empowers life sciences teams to effectively execute their responsibilities in a cohesive, user-friendly, and compliant setting. By combining functionalities such as DMS, RIM, QMS, eTMF, and eCTD, Kivo enables professionals in the pharmaceutical, biotechnology, medical device, and biologics sectors to manage regulated documentation, quality assurance tasks, clinical trial records, regulatory submissions, and workflow processes seamlessly, eliminating the complications associated with juggling multiple disconnected tools. With its Document Management System, Kivo allows users to oversee controlled documents and automate workflows, ensuring project monitoring, corporate documentation management, and due diligence preparedness in a streamlined manner through features like version control, collaborative tools, audit trails, robust search capabilities, workflow automation, and Part 11-compliant electronic signatures. Furthermore, the RIM component significantly enhances project oversight and communication, simplifies submission construction and publishing transitions, offers eCTD viewing alternatives, and optimizes dossier management and interactions with regulatory bodies. Overall, Kivo equips life sciences teams with essential tools that ensure compliance and boost operational efficiency, ultimately leading to improved project outcomes and a more organized workflow. This comprehensive approach not only addresses current challenges but also prepares organizations for future demands in the rapidly evolving life sciences landscape.

What is Ennov Regulatory Suite?

The Ennov Regulatory Suite stands out as a premier solution for managing regulatory content and information. This comprehensive, centralized platform facilitates the entire regulatory information workflow, spanning from initial stages to market authorization. Companies aiming for excellence in regulatory operations commonly adopt this approach because it fosters harmonization and promotes standardization, enhances collaboration while ensuring compliance, reduces waste and costs, accelerates time-to-market, and enables them to effectively compete in the global arena. The suite includes Ennov Doc, Ennov Dossier, and Ennov Process, which collectively support the complete regulatory product lifecycle, from the early phases of setting registration goals to the eventual retirement of products. By utilizing the Ennov Regulatory Suite, organizations can strategically plan their regulatory activities and streamline their processes efficiently. This makes it an indispensable asset for companies navigating the complexities of regulatory compliance.

Media

Media

Integrations Supported

Docusign
Ennov RIM
Gmail
Microsoft Word

Integrations Supported

Docusign
Ennov RIM
Gmail
Microsoft Word

API Availability

Has API

API Availability

Has API

Pricing Information

$1,800 per month
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Kivo

Date Founded

2021

Company Location

United States

Company Website

kivo.io

Company Facts

Organization Name

Ennov

Date Founded

1999

Company Location

France

Company Website

en.ennov.com

Categories and Features

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Categories and Features

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

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