Kivo Reviews & Product Details

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.

My company has used Kivo and it's previous version, Gemstone, for the past 6 years now. The biggest plus for Kivo is it's intuitiveness and ease of use. Having used other document repositories/QMS systems before, there is nothing more simple than Kivo. Plus the customer service is top notch, whether that is help with handling a task or asking for a new feature to be created Kivo is very quick to respond and able to build in your requests to their entire system. My company was so pleased with Kivo that we have now rolled out all their systems, regulatory, quality and clinical, to all our various functions. Review collected by and hosted on G2.com.

The only downside of Kivo is documents do not automatically get populated into the eTCD viewer after a regulatory submission and you need to do this manually. Review collected by and hosted on G2.com.

Kivo is extremly user friendly, which has allowed implementation of the RIM system seamless 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. As we shifted away from SharePoint and to Kivo we though the integration process across the company would be dificult, but so far we have had company buy-in and recieved great feedback. Review collected by and hosted on G2.com.

During review periods or "collaborations" it would be great if the "@" system would work, this makes it easier for collaborators to call out the most relevant individuals. We have yet to fully go through our IND, but thus far this is my takeaway. Review collected by and hosted on G2.com.

Kivo is a great tool for small organizations to store both business as well as regulatory documents. The system is user friendly and minimal training is required to become proficient to use the system. The folder structure is easy to follow so no documents get lost. Collaboration enables a distributed (remote) team to work together in real time to complete document content. Building regulatory submissions is a snap. The system eliminates excel spreadsheets and other trackers and the project management features provide a great summary view into content and submission planning, preparation, and completion. It's a "must have" for small companies preparing their first IND and scales well for small and mid-sized companies looking to prepare NDAs/BLAs/501Ks. Review collected by and hosted on G2.com.

There's nothing about it that is problematic for me. Review collected by and hosted on G2.com.

Built for the regulatory professional. Compared to other systems I've used, Kivo is more intuitive and customizable. The EDMS functionality is very efficient and the customer support is above and beyond. The new platform for project management has the potential to be a game changer for regulatory submission timelines/document management. Review collected by and hosted on G2.com.

The first time we used the collaborative review feature, it was not immediately clear how to best utilize the versioning function, but luckily Kivo provides lightning fast support and was able to advise us until we got the hang of it. The collaborative review versioning is slightly different than other systems I've used, but once you get the hang of it it's far better than others. Review collected by and hosted on G2.com.

Kivo provided exceptional customer support during our implementation process. They offered quick turnaround times and custom assistance to help us rapidly enhance our compliance efforts. Their professionalism and expertise significantly raised our confidence in achieving optimized compliance for our organization. Review collected by and hosted on G2.com.

I honestly can't say there has been anything that I can point to that we've had any issues or dislikes with the product or support. Review collected by and hosted on G2.com.

Simplicity of documentation is best. No onerous additional processes. Easily customizable. We are a small company and appreciated the Kivo team's help in getting us set up fast and their support in customizing. Review collected by and hosted on G2.com.

Admittedly, we have not yet used it enough to say what we dislike the most. We will keep the Kivo team up-to-date as we learn. Review collected by and hosted on G2.com.