The #1 Regulatory Management System for Life Sciences

Kivo RIM FAQs

What is regulatory information management (RIM) software and why is it important?

Regulatory Information Management (or "RIM") involves the systematic handling of regulatory data and documents throughout their lifecycle in industries such as pharmaceuticals, biotechnology, and medical devices. RIM software provides a central, cohesive system for  life sciences teams to manage that lifecycle of regulatory activities, from document creation and submission planning to correspondence tracking and health authority commitments. It's designed to replace disconnected tools like spreadsheets, email threads, and SharePoint folders with a centralized, compliant, and collaborative system.

RIM software helps life science organizations efficiently manage regulatory obligations, reduce risks, and ensure timely product approvals while maintaining compliance with applicable laws and regulations. Without a RIM solution, regulatory teams face increased risk of missed deadlines, version control issues, and costly submission delays. With software like Kivo RIM, companies gain speed, visibility, and control, making it easier to stay compliant while accelerating time to market.

When should a pharma or biotech company implement a RIM system?

Most teams start evaluating RIM software as they approach or enter clinical trials. That’s when the volume of submissions, agency correspondence, and cross-functional coordination becomes too complex for spreadsheets and siloed tools.

If your team is manually tracking commitments, juggling multiple regions, or struggling to scale your submission process, it's time. The earlier you invest in RIM, the easier it is to stay compliant and audit-ready as you grow.

What is the best RIM software for life sciences teams?

Kivo RIM is the highest-rated RIM software on G2, at 4.9/5. Beyond the rating, it's built for how regulatory teams actually work today: agency correspondence and health authority commitment tracking, real-time co-authoring through Microsoft Office Online, and lifetime, pre-validated compliance out of the box. Legacy RIM platforms carry decades of brand recognition but often lag on usability and modern needs like combination product development. Kivo RIM matches their core functionality — submission assembly, eCTD management, dossier management — while staying easy to learn and fast to support. Schedule a demo to see why our customers agree.

What features should I look for in a RIM system for global submissions?

When dealing with global submissions, your RIM system needs to support submission planning across multiple regions, track health authority interactions, and provide real-time visibility into the status of every activity. It should also allow you to manage country-specific requirements and keep everything aligned with agency expectations.

Critical features include eCTD viewing, correspondence tracking, dossier management, configurable workflows, and integrations with your document control and quality systems, all of which are provided readily and easily within Kivo RIM.

How much does RIM software cost?

Legacy RIM platforms often require six-figure budgets, months of implementation, and extensive training. Kivo RIM offers team plans with transparent, published pricing — including IQ/OQ/PQ/UAT validation documentation, standard implementation, and unlimited support. Pricing is based on the number of licenses you need — visit kivo.io/pricing for current rates.

Can RIM software integrate with our QMS, CTMS, or ERP?

Absolutely, and Kivo RIM makes it easy. Our platform is designed with seamless integration in mind, whether you're connecting to your QMS, CTMS, eTMF, ERP, or other critical systems. With Kivo, you can streamline data flow across your regulatory, quality, and clinical operations, eliminating manual work, reducing risk, and ensuring nothing slips through the cracks.

We offer Single Sign-On (SSO), APIs, and GxP-compliant data import-export, so your systems stay fully connected, compliant, and audit-ready from day one. No messy workarounds, no data lock-in. Just clean, secure data management that scales with you.

How does a RIM system help with eCTD submissions and tracking?

While many legacy RIM platforms claim to support eCTD workflows, they often rely on clunky interfaces and disconnected document tools, or they require heavy customization to create compliant structures. You may end up doing more manual work, juggling add-ons, or needing external publishing tools to get across the finish line.

Kivo RIM was built with submission-readiness at its core. Our RIM software takes the complexity out of eCTD submissions by giving your team a smarter, faster way to manage every step of the process. With pre-built structures for INDs, CTAs, NDAs, etc., you can move from draft to submission-ready with confidence.

Kivo RIM's built-in eCTD viewer lets regulatory operations teams review and validate submissions directly in the platform. You get full visibility, version control, and peace of mind, all in one intuitive system that’s built to scale with your pipeline.

Does Kivo support eCTD publishing?

Kivo helps your team prepare your submission for publishing and manage your submitted eCTDs afterward. Your team assembles content against pre-built submission templates and content plans, exports a publishing-ready package with automatic change tracking, and hands off to your internal or external publishing group.

Submitted eCTDs are then viewable in Kivo with every document linked back to its source in the DMS — so when a health authority asks about something you filed two years ago, you find it in seconds.

Unlike some other vendors, Kivo doesn't white-label a third-party publishing tool and mark it up, and doesn't lock you into one publishing vendor.

What happens if we don’t have a proper RIM system in place during clinical trials?

Without a dedicated RIM system, regulatory teams are forced to rely on spreadsheets, email threads, and disconnected tools to manage high-stakes submissions. This approach may work in the early stages, but it quickly breaks down as timelines accelerate, global requirements multiply, and cross-functional teams grow. The result? Missed deadlines, duplicate work, lost version history, and a serious lack of visibility, especially when working across multiple regions, partners, or contract organizations.

These gaps don’t just slow you down. They expose your company to real regulatory risk. A delayed response to a health authority, a misfiled document, or a missed commitment can trigger everything from agency findings to full clinical trial holds, each of which comes at a cost to your operations, finances, and reputation. 

While legacy systems have discouraged many smaller teams from transitioning quickly from homegrown data management tools to a dedicated RIM system, we developed Kivo to make best-in-class RIM software accessible to life science teams of every size. Our system centralizes your regulatory workflows, tracks every milestone and commitment in real time, and gives your team the tools they need to execute quickly, accurately, and confidently. As your trials get more complex, Kivo RIM helps you stay in control, stay compliant, and stay ahead of regulatory expectations.

How long does it take to implement Kivo RIM?

Unlike legacy RIM systems that can take 6–12 months to implement (and require dedicated IT teams), Kivo RIM is designed for fast, low-friction implementation. Many customers are up and running within just a  few weeks, and our intuitive interface, pre-configured structures, and expert onboarding support make it easy for your team to start seeing value quickly.

We also include lifetime validation and industry-leading support in our pricing, so you’re not hit with surprise fees down the line. Whether you're migrating from a patchwork of tools or replacing a legacy platform, Kivo helps you make the transition smoothly, without disrupting your ongoing submissions or timelines.