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.
Our prior experience includes working with the FDA on the first electronic submission processes, building secure cloud infrastructure for the Fortune 1000, running agile development for enterprise software teams, and over 100 years of combined regulatory and clinical operations experience. Fast-forward ten years (and a new name)… today Kivo powers hundreds of drug applications and clinical trials for more than 50 global sponsors and their partners.
50+
Teams rely on Kivo to control costs and accelerate time to market
100+
Regulatory applications managed in Kivo by sponsors and partners
60+
Clinical trials running on Kivo, either active on in long-term storage
100+
Years of regulatory & clinical expertise inform Kivo's intuitive solutions
It’s not 2007 anymore, or even 2019
The world of drug discovery and development has changed. In a market once dominated by ‘big pharma’ studies, today over 70% of active drug trials are sponsored by small, fast-moving teams backed by venture and private equity investors.
These teams are now distributed across departments, time zones, and geos - and their success depends on leveraging efficient systems, reliable partners, and effective project management. Unfortunately, the systems to support distributed, fast-moving life science teams haven’t evolved as quickly.
Work works differently when it’s regulated.
Validation, GxP, CFR Part 11 compliance - these aren’t industry buzzwords, they’re 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 an ‘enterprise suite’. What’s worse, both these paths create even more division (‘silos’) between the Regulatory, Clinical & Quality teams that need to be working more closely together.
Kivo brings life sciences teams together.
We offer a shared workspace where every department - Regulatory, Clinical & Quality - can manage their documents (SOPs, INDs, TMFs), their projects (submissions, trials, docs) and even their vendors 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. Oh, and it doesn’t cost six figures or take six months to set up (more like 6 days).
Come Work with Us
We’re always looking for talented individuals to join us. Visit our careers page to see if any positions are currently available.
Kivo News
Enhance clinical and regulatory document submission knowledge at your organization with industry-leading resources.

Prepare Your Clinical Trial Application in the US: A Guide to the Investigational New Drug (IND) Application
In this article, we'll walk you through what an IND is, what the application should include, and how to work alongside the FDA for maximum success.

How To Implement a RIM System: Part 1
RIM (Regulatory Information Management) refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products...


Prepare Your Clinical Trial Application in the US: A Guide to the Investigational New Drug (IND) Application
In this article, we'll walk you through what an IND is, what the application should include, and how to work alongside the FDA for maximum success.

How To Implement a RIM System: Part 1
RIM (Regulatory Information Management) refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products...

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