Pricing that's right-sized
(for teams of any size)
Pay for only what you need, without the enteprise overhead.
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✅ Validation Included
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✅ Training Included
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✅ Support Included
- Starts at 5 Full users; add more in increments of 5 or 10
- Includes "Read-Only" licenses for training & e-signatures
- Base Package comes with Kivo DMS & Training, along with 1 Module (QMS, RIM, TMF)
- Part-11 eSignature included at no extra charge
- Validation included , both up-front & ongoing
- Training, Maintenance & Support all included
- Add other modules (RIM, eTMF, QMS) at any time
- ICH Authoring templates (optional package)
- SOPs to cover Kivo operation (optional package)
- Migration of existing docs & data (scoped separately)
- Kivo Services available for add'l ongoing support
- Starts at 100 users; add more in increments of 10 or 20
- Includes "Read-Only" licenses for training & e-signatures
- Base Package comes with Kivo DMS & Training, along with 1 Module (QMS, RIM, TMF)
- Part-11 eSignature included at no extra charge
- Validation included, both up-front and ongoing
- Training, Maintenance & Support all included
- Add other modules (RIM, eTMF, QMS) at any time
- ICH Authoring templates (optional package)
- SOPs to cover Kivo operation (optional package)
- Migration of existing docs & data (scoped separately)
- Kivo Services available for add'l ongoing support
Powering Innovative Sponsors & Service Partners Worldwide
Sample Pricing Scenarios
Our pricing is flexible based on number of users, user types, migration needs, and customization.
An Emerging Biotech using DMS + QMS
Kivo's Base Packages comes with our Part-11 Compliant DMS, as well as one module (QMS, TMF, RIM) and Up to 10 Users.
Many smaller teams start with Kivo's QMS, as they are looking to manage SOPs, Training & Quality Activities in a compliant manner.
👉 A team like this might pay $29,000 / year for Kivo's DMS + QMS & Training solution, with a one-setup fee of $5,000.
An Enterprise Team w/ Full System Migration
Larger teams typically require more users, and are often moving to Kivo from their existing Quality, TMF and/or Regulatory Solutions.
Kivo can provide full system migration services, with pricing plans to accommodate hundreds of users.
👉 A team with 100+ total users - including Read-Only users who can Train & eSign - might expect to spend $85,000 /year for the Kivo platform, with a one-time system implementation and migration fee starting at $25,000.
Security & Trust
Security and data integrity is at the heart of what we do. We help our customers achieve compliance, and that starts with us.
Security & Architecture
- Single Sign On (SSO), Multi-Factor Authentication (MFA) Ready
- User Attack Vector Protection: Bot Detection, IP Throttling, Brute-force Protection, Breached Password Detection
- All data uses 256-bit encryption in transit and at rest
- Multi-continent data failover and auto-scaling
- Highly granular user permission model to control access including a secure document viewer that prevents downloading, printing, or copying text from documents
Validation Approach
- Qualification, testing, and validation approaches aligned with software and GCP best practices
- Complete OQ in a validation environment conducted prior to each release, screenshots provided
- UAT in production as part of each release that includes major process and performance considerations (over 800 tests)
- Validation package loaded into your Kivo workspace for each release
- SOP packages updated with each release
DON't take our word for it
Recent Reviews
Tara G
CEO & Principal Consultant
"Kivo is a QMS & RIMs game changer. It competes strongly against its Goliath peers. From onboarding to troubleshooting, their team has been a reliable partner at every step."
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."
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."
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."
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."
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."
Request a Demo Today
Kivo Pricing FAQs
Yes.
Kivo's modern, configurable architecture and CSA validation approach allow us to right-size our pricing for smaller teams - in a way that other solutions can't match without significantly limiting their functionality.
Our goal is to offer life sciences teams of any size an efficient and compliant way of working together, and our pricing reflects that.
To get a price quote, book a demo. Or, check our third party reviews on G2 to hear what our customers have to say.
Kivo was designed and developed specifically to align with the FDA's Computer Software Assurance (CSA) guidelines. This replaces the legacy documentation-heavy approach with a "risk-based, least-burdensome" framework.
For every release, Kivo provides a complete validation package to every customer instance, including IQ, OQ, PQ, and UAT. This allows Kivo and our customer teams to maintain a continuously validated state.
The standard Kivo setup fee - which includes configuration, training, go-live, and support - starts at just $5,000.
Typically, each module requires its own setup, although implementation projects can run in parallel.
Your total Kivo subscription cost will depend on 1) which modules you select, and 2) the total number of users you require.
Both are easy to add as your team grows, keeping Kivo's cost right-sized.
To get an exact quote, book a demo today!

