Regulatory information management (RIM) is not just a compliance task to cross off your preclinical checklist.
How you manage regulatory information can either give you a major competitive edge or create a never-ending series of roadblocks that can completely derail your development timeline.
In this guide, we’ll walk you through how to approach RIM as things get more complex in the transition to clinical development. And more importantly, we’ll show you how to turn RIM from a cost center into a strategic advantage that helps you move faster, reduce risk, and scale smarter.
This guide is provided by Kivo, developers of the only RIM software with real-time collaboration, lifetime validation & no hidden fees. We make it ridiculously easy to find, organize, and manage your data, our UX doesn’t require advanced training to use, our support replies within 5 minutes during business hours, and we cost 1/10 of the legacy RIM systems that offer none of those things. Click here to book a demo, and see how Kivo can make your life easier AND give your team a competitive edge.
Regulatory information management (RIM) is the discipline of organizing, tracking, and maintaining all regulatory data and documentation related to a product's lifecycle, from development to approval and beyond.
Or in other words, it’s how you organize, track, and manage all the regulatory data, documents, and activities involved in getting and keeping your products on the market.
RIM is often misunderstood as simple document storage or compliance tracking — mostly because that’s how small teams tend to approach it initially — but once you begin preparing for clinical trials, simple document storage and compliance tracking aren’t enough.
Gens & Associates, a leading research firm specializing in Regulatory Information Management, outlines 15 key benefits a great RIM approach should provide, broken into 5 categories:
These benefits don’t just happen automatically or simply from choosing a RIM system. They emerge when an organization matures its regulatory capabilities across people, process, and technology.
The model below from Gens & Associates outlines the path to high-performance RIM. It emphasizes that the highest-performing regulatory teams focus not only on the tools they use, but on building the right organizational foundation to support those tools.
RIM provides a single source of truth for all regulatory activities, enabling faster decisions, smoother inspections, and better risk management. Failure to manage regulatory information correctly can lead to delayed product launches, penalties, or reputational damage.
The regulatory landscape isn't what it used to be. It’s more complex, more global, and more demanding. For life sciences companies facing tighter budgets and stiffer competition, the margin for error is vanishing fast.
Many teams are still relying on spreadsheets, disconnected storage systems, and endless email chains to manage compliance-related tasks. That might have worked in the past (barely), but today it opens the door to critical issues like:
When data is fragmented and documentation lives in five different places, it’s not a matter of if something will go wrong... but when.
And when it does go wrong, the costs can be staggering. According to Wolters Kluwer’s Regulatory Violations Intelligence Index, regulators issued 199 violations in the first half of 2024 alone, totaling $1.876 billion in penalties.
But fines are just the tip of the iceberg. Regulatory failures can delay approvals, trigger product recalls, invite legal scrutiny, or even derail entire clinical trials. We've seen companies forced to repeat full studies, not because the science was wrong, but because their submissions didn’t meet data structure or traceability requirements.
In a hyper-competitive industry, these kinds of delays don’t just hurt. For smaller businesses, they can be fatal.
Regulatory bodies are modernizing and expecting sponsors to do the same. The FDA and EMA now require structured, electronic submissions and demand end-to-end traceability. Data must be secure, validated, and audit-ready at all times.
A modern RIM system acts as the connective tissue between your internal teams and external regulators, ensuring everything from labeling changes to global submission tracking is compliant, consistent, and up-to-date.
Beyond regulatory compliance, the pressure for visibility is rising from investors and customers alike. Stakeholders now expect transparency and accountability across the entire product lifecycle.
From early trials to post-market surveillance, companies are expected to prove not just what happened, but why, and that requires structured, centralized, and defensible data.
And you don’t just need defensible data for inspections. You need it for fundraising, board reviews, license deals, partnerships, divestments, and so much more. Having all your data in one, compliant workspace quickly becomes a strategic advantage.
Click here to join our webinar on how to leverage data management as a competitive edge during times of high volatility within the markets and regulatory agencies.
Now that we’ve established what’s at stake, let’s look at the challenges of RIM and discuss why modern life sciences teams need a dedicated Regulatory Information Management System to keep up.
For many regulatory and operations teams, the problem isn’t understanding why RIM matters, it’s wrestling with the frustrating, time-consuming, and high-stakes problems that happen when systems and processes can’t keep up with the complexity of global compliance.
Whether you're using a legacy vendor, patchwork tools like SharePoint, or a homegrown system of spreadsheets and email threads, the following challenges can quickly turn into multi-million dollar problems:
Each of these issues might feel manageable in the early stages, but once you reach clinical trials, the margin for error vanishes, and even the most popular legacy RIM systems begin to fall short.
And let’s be honest, even if we ignore the high-stakes issues at play here, herding cats is not what you want to be doing all day.
If your system makes it easy to find, track, and store documents with compliance built into the workflows, that lets regulatory professionals focus on the more meaningful aspects of their jobs: strategy, intelligence, risk mitigation, etc.
A modern Regulatory Information Management (RIM) system is more than a database. It’s the backbone of how your organization collects, manages, tracks, and reports regulatory data across the product lifecycle.
The right system doesn’t just help with compliance, it accelerates decision-making and improves collaboration between regulatory affairs, quality, operations, and IT.
Here are the four essential components every robust RIM system should include:
Regulatory documents need to be stored, tracked, and easily retrieved, often years after submission. A strong RIM system:
This minimizes the risk of using outdated files and ensures alignment across teams and geographies.
One of the most central benefits of a RIM system is making submissions easy to assemble, export, and track. A good RIM platform:
This supports planning, prioritization, and rapid responses to regulator queries.
A RIM system must be inspection-ready at all times. Key features here include:
This ensures transparency and confidence when regulators come knocking.
Managing communication with health authorities isn’t just about tracking emails. It’s about capturing every promise made, every question answered, and every request fulfilled.
A modern RIM system should:
This helps ensure that no request falls through the cracks. Strong correspondence and commitment tracking means fewer surprises, faster responses, and better regulator relationships.
These are the basic components of what makes RIM systems so essential for regulatory information management. But they aren’t everything you should be looking for when choosing a system that is right for your team.
Not all dedicated RIM systems are created equal.
The most popular legacy systems are ridiculously clunky, wildly expensive, and have indefensibly slow customer support.
They don’t need to have the best product or support, because many large companies in the industry have been using them for over a decade.
This means that smaller companies have the opportunity to secure a major competitive advantage by using a modern RIM system with a better user experience, faster support, and modern architecture.
If you’re looking to start with a dedicated RIM system or transition from an existing system, you should demand the following six features from the system you choose (oh, and we built Kivo specifically to offer these features and fill in the gaps left by the legacy providers... at 1/10th of the cost they charge).
Your regulatory team shouldn’t need weeks of training or a full-time system administrator just to navigate your Regulatory Information Management software. If the platform feels clunky, confusing, or overly complex, your team will have to find workarounds, adoption will stall, and data quality will suffer.
Regulatory teams already operate under pressure. When every submission carries real deadlines and consequences, your tools should reduce friction, not add to it. That’s why modern RIM platforms must be clean, intuitive, and purpose-built for how regulatory teams actually work.
At Kivo we treat ease-of-use as fundamental to compliance and productivity. From centralized dashboards to simple submission workflows, we’ve designed our system to feel familiar from day one.
“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.” — Marissa B. Senior Manager of Regulatory Strategy
The most popular legacy RIM systems have slow support with turnaround times averaging 72 hours or more. When the FDA sends your team an RFI with a 24 hour response window, and you need help navigating a complex interface or dealing with a software bug... what do you do?
There’s not much you can do... except watch your submission be paused, delayed, or outright rejected.
Here at Kivo, we think that’s nonsense, and that’s why we have an average response time of 7 minutes. Yes, you read that correctly: 7 minutes. Prioritize vendors that offer same-day responses and understand the time-sensitive nature of your work.
“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.” — Nathan R, VP of Product
Few industries are evolving as rapidly as life sciences and drug development, and legacy RIM systems are NOT designed to handle things like combination products, new platform technologies, and complex submissions.
Kivo was designed specifically with adaptation in mind, and we specialize in supporting combination products, hybrid workflows, cross-functional collaboration, and other non-traditional product structures.
“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.” — Verified G2 Review
A modern RIM platform should give your team instant, filterable insight into every submission, commitment, or regulatory event. That means being able to quickly answer questions like:
This level of visibility doesn’t just reduce stress, it makes it possible to proactively manage risk, keep launches on track, and respond to regulators with confidence. It’s one of the clearest signals that your RIM system is doing its job.
Kivo gives you easy, immediate access to all critical submissions data, whenever you need it.
“My regulatory team and I have much higher confidence that we are sending the right version of a document.” — Kristi N, VP of Regulatory Affairs
A modern RIM system should enforce consistent document workflows with built-in version control, granular permissions, and role-based access. That means every action is time-stamped, attributed, and fully traceable — no guesswork, no digging through email threads to prove compliance during an inspection.
Robust systems like Kivo also support key global compliance frameworks, including 21 CFR Part 11 e-signatures, EU Annex 11, ICH guidelines, and GDPR, ensuring that your processes meet regulator expectations across all regions.
Without this kind of structure, it’s easy for users to bypass procedures, create unauthorized versions, or misplace critical records. And if your team can’t clearly demonstrate control during a health authority audit, that can lead to approval delays, CAPAs, or reputational damage.
At Kivo, we’ve built inspection readiness into the foundation of our platform, so your data stays clean, your teams stay aligned, and your submissions are always backed by the evidence regulators expect.
Kivo even has a user role specifically for inspectors, so you can walk them through a streamlined version of your trial narrative.
The inspector role also works for investors, partners, and anyone else who needs an overview of your data.
“If an inspector asks for data, I don’t have to go to a fireproof safe, pull out a USB, load it somewhere, and try to print a file. I can just grant an inspector access to the platform with controls and permissions already in place.” — Matt W, Executive Director of IT
One of the biggest myths in the RIM space is that you need to spend like an enterprise to operate like one. Legacy vendors often lock companies into long-term contracts, expensive add-ons, and bloated pricing models, even for basic functionality like additional users, extra storage, or core features you assumed were included.
Kivo gives you everything you need at a tenth the cost of legacy systems, AND it scales with you, seamlessly and affordably, as your team and needs grow.
Plus, as your team grows, you can scale with us into other R&D functions with both clinical solutions (TMF) and quality solutions (QMS) available on our platform.
“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.” — Ken V., CEO
Kivo is the only RIM system with real-time collaboration, lifetime validation & no hidden fees. We make it ridiculously easy to find, organize, and manage your data, our UX doesn’t require advanced training to use, our support replies within 7 minutes during business hours, and we cost 1/10 of the legacy RIM systems that offer none of those things.
Whether you are choosing your first dedicated RIM software or looking for a change that will massively reduce costs while also giving your team a competitive advantage, you owe it to your team to give Kivo a try.
Click below to book a demo and see why so many life sciences teams are transitioning off legacy systems and using our modern RIM software instead.