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About us

Hi! We're Kivo.

We’re a team of regulatory experts and software architects who came together to create a better document collaboration solution for today’s emerging life science teams.

Starting in 2012 with our original 'Gemstone' platform, we've been building our expertise working with fast-growing life sciences teams - and realized that these teams need a solution built specifically for their size, scale, and distributed way of working.

Rebranding as Kivo in 2021, we committed ourselves to creating a solution that is:

  • Intuitive: Easy to set up and use with little-to-no training
  • Unified: A single system that Reg, Clin & Qual teams can all rely on
  • Compliant: 100% Part 11 compliant; always audit & diligence-ready
  • All-inclusive: Comes with validation & support
  • Affordable: Pricing for teams of 5 or 500

So we developed Kivo GO, our flagship platform now trusted by sponsor and service provider teams around the world as they develop programs, gain regulatory approval, acquire / divest / launch products - and bring critical medicines to market.


Teams rely on Kivo to control costs and accelerate time to market 


Regulatory applications managed in Kivo by sponsors and partners


Clinical trials running on Kivo, either active on in long-term storage


Years of regulatory & clinical expertise inform Kivo's intuitive solutions

Why do small & scaling life sciences teams need a new solution?

It’s not 2007 anymore, or even 2019

The world of drug development has changed. In a market once led by ‘big pharma’, today over 70% of active drug trials are sponsored by small, fast-moving teams backed by venture and private equity investors.

These teams are distributed across time zones, and geos - and their success depends on the efficient use of systems, partners, and funding.

Work works differently when it’s regulated.

Validation, GxP, CFR Part 11 compliance - these are core to how drug development teams must design and scale their operations as they file submissions, manage trials, and work with regulatory agencies. But for too long, these teams have had to choose between using a patchwork of file and project management tools - or taking the six-figure, six-month plunge with legacy compliance solutions. 

Kivo brings life sciences teams together.

Kivo GO offers a shared workspace where every department - Regulatory, Clinical & Quality - can manage their documents and projects in a way that’s intuitive, efficient and, of course, compliant. No more chasing files around, battling user permissions, or managing projects in Excel.

Kivo brings everything together in one connected, compliant workspace that teams actually like using.  And setup takes days, not months.

What our customers are saying

Recent Reviews

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."

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."

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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