Kivo Reviews & Product Details

Easy to use, intuitive, and well supported. The user interface is friendly and simple to navigate, and the full-text search makes finding documents quick and efficient. It’s also easy to create numerous reports to help manage workflow and track status. The Kivo team is amazing and transparent, and they actively encourage feedback to keep their QMS relevant and top-tier. When we generate tickets, their responses are timely and lead to clear resolutions—usually the same day and often within the hour. The platform performs well overall; we use it as a QMS, LMS, and eTMF, and our team appreciates the one-system approach instead of piecing together several different platforms. Many of our suggestions have been implemented and/or queued for exploration and later implementation; their responsiveness to these needs is valuable and reinforces their role as a trusted partner. They use cutting-edge AI features to enhance their product's functionality. Review collected by and hosted on G2.com.

I wouldn't say I dislike anything specific in Kivo. It is a great product, and they are growing and expanding their capabilities, which seems to be ongoing. So when I approach them with a need, they usually already have something in the pipeline. Review collected by and hosted on G2.com.

Kivo's service task overview provides a comprehensive look at all ongoing tasks, ensuring that nothing falls through the cracks and that all regulatory requirements are met efficiently. Review collected by and hosted on G2.com.

What I like best about Kivo is how responsive and customer-focused the team is. They’re always easy to reach when we have questions or need support, and they genuinely listen to customer feedback and use it to improve the platform. Unlike other RIM systems we’ve used that can be rigid in their approach, Kivo is flexible and continues to evolve based on what customers actually need. The platform itself is simple, scalable, and easy to use, which makes it a great fit for regulatory teams. Review collected by and hosted on G2.com.

The document library mirrors the eCTD structure, including the regional Module 1 sections for the US, EU, and Canada. Source documents can be filed exactly where a regulatory reviewer would expect to find them, and the same structure works consistently across multiple health authorities. Submissions are organized by agency and application, so even a multi-country program with many parallel filings remains easy to navigate and follow. Entire submission packages can be imported in the same form they were filed, and the submission viewer lets you review a published sequence without having to leave Kivo. Review collected by and hosted on G2.com.

The regulatory activity tracker can be a bit cumbersome to populate when you need to cover multiple health authorities, but you can work around this by importing Excel-generated trackers. These can be updated easily outside the system and then brought back in as needed. Review collected by and hosted on G2.com.

Not having to worry about Validation status saves a ton of time, money and effort. The interface is intuitive and people pick up on how to use it quickly. Review collected by and hosted on G2.com.

Needs to complete integration with Microsoft accounts, so features like @ mentions work the same way they do in Sharepoint. Review collected by and hosted on G2.com.

They have great customer service. The DMS is intuitive and fast. It's very customizable, and the support is some of the best I've ever experienced. Review collected by and hosted on G2.com.

It's objectively expensive, but it's very reasonable in it's market. Review collected by and hosted on G2.com.

I like KIVO because it’s easy to use, intuitive, and fast. Its straightforward design makes it simple to navigate, keeps my workflow streamlined, and lets me complete tasks efficiently without any unnecessary complexity. Review collected by and hosted on G2.com.

Nothing really stands out, but it’s a good system overall. Review collected by and hosted on G2.com.

At BioEthica, we are committed to maintaining the highest standards of quality and regulatory compliance across all our FDA-regulated projects. After evaluating several well-known platforms, we selected Kivo to support our own internal Quality Management System (QMS), Regulatory Information Management (RIMs), and client-facing documentation workflows. The result has been an exciting experience, and we've recommended Kivo to our clients too, also implementing Kivo solutions.

We also love Kivo’s seamless, user-friendly dashboard. It’s visually intuitive and logically organized, making it easy to navigate even for first-time users. The platform’s usability and customization options have made it easy to tailor Kivo to our specific needs.

What truly elevates the Kivo experience is their excellent customer service and support team, who are responsive, knowledgeable, and genuinely committed to our success. From onboarding to troubleshooting, their team has been a reliable partner at every step. The personnel are fun, smile, are polite and polished. The training provided was top-notch—clear, efficient, and tailored to our users’ needs—ensuring smooth adoption across the board.

Looking ahead, we’re excited to see Kivo launch their eTMF solution. Given their track record, product quality, and the smoothness of our own BioEthica implementation, we are confident this new feature will stand shoulder-to-shoulder with the top eTMF systems commercially available today. With Kivo’s expertise, commitment to usability, and flexible platform, we’re certain their eTMF will be another industry standout.

In short, Kivo has become an indispensable part of our digital infrastructure. Its powerful functionality, intuitive design, and outstanding support have exceeded our expectations. We highly recommend Kivo to any organization looking for scalable, compliant, and collaborative regulatory and quality solutions. Review collected by and hosted on G2.com.

We want to see even more and hope Kivo can get into more project management, tracking of project time against billables for SOWs (would be good for CDMOs, CROs and consultancies) and ESG submission solutions in the future, in short, the only thing we didn't like is that they don't offer more. Review collected by and hosted on G2.com.

Best bang for the buck of any electronic QMS out there. Intuitive organization and interface, similar in concept to the traditional paper QMS; learning curve is minimal for users already experienced in Quality. Excellent, responsive customer service. Simple implementation. Review collected by and hosted on G2.com.

Some features (e.g., electronic signatures) are not completely built and require workarounds (e.g., Kivo-provided free Part 11 DocuSign for electronic signatures). Review collected by and hosted on G2.com.

Kivo is a "right sized" tool that allows a life sciences company to establish and maintain compliance with regulated documentation practices without going overboard on complexity. Even better, the tool's integrated, but multiple module approach allows companies to customize what functions are used, allowing for a company to share documents across multiple groups, while keeping both cost and complexity to a minimum.

In our organization, we've used multiple, but not all Kivo capabilities to deliver exactly the cloud-based functionality we need. It's straightforward enough that training is minimal and user uptake is very high with a short learning curve. The fact that it's deployed validated and Kivo maintains validation status as part of the model is invaluable. Review collected by and hosted on G2.com.

Increased use of drag and drop for document management functions (move, link, clone, etc) would be a really nice plus. Review collected by and hosted on G2.com.

For context, I work in regulatory affairs/regulatory strategy/medical writing at a pharmaceutical company. My job involves regulatory document archiving, writing, and review, as well as planning/assembling submissions to health authorities. Keeping files organized and easy to find is a big deal for me.

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. We implemented Kivo at our small company of 35+ employees, which spans multiple countries and continents. The Kivo system has been easy to use for everyone. Kivo makes the process incredibly easy for file storage, document creation using their eCTD templates, document editing, collaborative authoring/review, submission building, and more, and we love how much it offers under a single vendor/software package. Other roles at my company make use of the eTMF and QMS systems within Kivo, and I'm looking forward to making use of some of the new project management features in Kivo.

We rarely have any technical problems with Kivo, but on the rare occasion we do, the customer support team is very quick to respond and resolve the issue. They are always happy to answer any questions or teach me new features that have been added to Kivo.

Kivo makes the logistical and administrative aspects of my job easy, especially because it has been so easy for my non-regulatory colleagues to learn and use. I wholeheartedly recommend the Kivo system to any pharmaceutical company looking for ways to get organized and manage quality compliance. With all that Kivo has to offer, I can't imagine using anything else. Review collected by and hosted on G2.com.

Honestly I am struggling to think of the downsides of Kivo. Anything that I would have considered to be missing in the past (e.g., eCTD viewer or project management features) has now been added to the system. Looking forward to see what comes next! Review collected by and hosted on G2.com.