The Regulatory, Clinical, and Quality platform your team (& CFO) will love.

DMS | RIM | QMS | eTMF

Kivo is an affordable document & process management system that helps life sciences teams get work done in one intuitive, compliant workspace.

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Powering Innovative Sponsors & Service Partners Worldwide
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Purpose-Built for Scaling Pharmaceutical and Life Science Teams

Kivo offers a shared workspace where every function can manage their documents, programs and even vendors in a way that's intuitive, efficient and - of course - compliant. And our all-inclusive pricing means that everyone has access, without breaking the bank.

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Solutions for Every Team

Regulatory, Clinical, and Quality can all work in Kivo. 

Regulatory
Clinical
Quality
Commitments & Correspondence
Submission Assembly
Project & Dossier Management
eCTD Viewing
ICH Document Templates
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Active Trial Management
Site Management
Inspection Readiness
End of Study TMF Transfer
Long-Term Storage
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CAPA Management
Vendor Audits
SOP & Training Management
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Experience + Support = Awesome

With decades of experience in both regulatory and cloud-based software, 
Kivo offers best-in-class support and security, tailored specifically to the life sciences industry.

Visit Our Trust Center

CASE STUDY

Doubling Programs in 2 Years: How Hyloris Scaled Clinical, Regulatory and Quality with Kivo

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Real Human Support
Real Human Support
  • Sub-5-Minute Response Time
  • Unlimited Support Included
  • Unlimited User Training
security
Best-in-Class Security
  • SOC 2 Type 1 Certified
  • Validated Out of the Box
  • Customizable Access Permissions
  • CFR Part 11 Compliant
  • Quarterly Data Integrity Checks
  • Single Sign-On - No IT Required
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Implement Within Weeks
  • No Implementation Fee
  • No Validation Fee
  • Up and Running Within Days

No Hidden Fees. (Seriously.)

Say goodbye to unexpected fees with Kivo, including:

No platform fees
No implementation fees
No feature fees
No support tier fees
No per study fees
No maintenance fees
No per GB storage fees
No validation fees
What our customers are saying

Recent Reviews

marissa_b
Marissa B.

Senior Manager, Regulatory Affairs

"I have been using Kivo daily for over 2 years to manage 15+ drug development programs. It was extremely easy to learn and very intuitive for a regulatory affairs professional. Kivo makes the process incredibly easy."

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Seppe G.

Director of Regulatory Affairs and Quality Assurance

"The intuitive on-line interface has been adapted quickly by the entire development team allowing both the CMC experts as well as the clinical team to seamlessly integrate internal documents as well as controlled documents from external parties."

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Veronique V.

Quality Assurance Manager

"We're very happy to have all our documents stored in the same place. It's efficient to have a system where the review of a doc can be done simultaneously by several reviewers. The Kivo team is always ready to help and always listen to customer needs. Really appreciated."

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Kristi N.

VP of Regulatory Affairs

"Kivo was really fast to set up training, and then because the system is so user-friendly, it just didn’t take that much time to get people up to speed. Normally the learning curve with a system like this is quite steep, but Kivo is so intuitive we can quickly get people oriented and off to the races."

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Brian A.

Senior Manager, Regulatory Affairs

"Kivo is extremely user friendly, which has allowed implementation of the RIM system seamlessly throughout our company. The Kivo team has been great in walking us through the various questions we have and implementing feedback to better enhance our experience."

See what's possible with Kivo today.

"With all that Kivo has to offer, I can't imagine using anything else."

- Senior Manager, Regulatory Strategy 

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Kivo FAQs