For today’s regulatory teams, the pressure is constant and accelerating. Global market expansion, evolving regulations, and compressed product timelines all demand more, yet most regulatory affairs (RA) teams are asked to deliver with the same limited resources.
Managing hundreds of submissions across regions, coordinating with internal and external stakeholders, and keeping up with changing compliance requirements can quickly overwhelm even the most experienced teams. To better understand the measurable business value of modernizing regulatory operations, RegDesk commissioned Forrester Consulting to conduct a Total Economic Impact™ (TEI) study.
This independent analysis, published in October 2025, examined how organizations use RegDesk’s Regulatory Information Management System (RIMS) to improve efficiency, reduce risk, and accelerate market access. The results are striking.
According to the study, organizations using RegDesk achieved a 196% ROI, realized $2.6 million in net present value (NPV), and reached payback in less than six months. Beyond the numbers, the research reveals a clear story of transformation, where regulatory teams move from fragmented, reactive processes to connected, intelligent operations that drive measurable business outcomes.
Why Measuring RIMS Value Matters
For many organizations, regulatory operations have historically relied on manual tracking, shared drives, and email-based workflows. These fragmented systems make it difficult to maintain consistency, ensure visibility across markets, and respond quickly to change.
As one director of regulatory affairs for a dental devices company noted, “We would miss deadlines and either have to pay a fee or just stop sales.”
This lack of visibility not only slows time-to-market but also creates compliance and revenue risk. Without centralized intelligence, teams often duplicate work, over-rely on regional consultants, and struggle to plan effectively for product or labeling changes.
In this environment, regulatory leaders are increasingly under pressure from the C-suite to justify investment with tangible metrics. It’s not enough for a RIMS to “make work easier”, it must prove clear ROI, measurable efficiency gains, and risk reduction.
That’s exactly what the Forrester TEI study set out to measure.
Key Findings from the Forrester Study
Forrester’s independent research quantified the total economic impact of implementing RegDesk across multiple global organizations. The findings show that RegDesk not only improves regulatory performance but also delivers multi-million-dollar value through operational efficiency, cost savings, and avoided revenue loss.
Financial Impact
- 196% ROI over three years
- $2.6 million NPV
- Payback period of less than six months
These results demonstrate how quickly RegDesk’s platform delivers value by streamlining submissions, improving visibility, and enabling faster, more informed regulatory decisions.
Time Savings
- 1,040 hours saved annually per RA research specialist
- 360 hours saved annually per IT team member
By automating manual research, validation, and documentation processes, RegDesk frees regulatory specialists to focus on high-value strategic work.
Operational Efficiency and Risk Reduction
- Centralized access to country-specific requirements, submission timelines, and documentation
- Reduced reliance on external regional consultants
- Improved accuracy, audit readiness, and compliance consistency
One regulatory manager explained the shift clearly: “RegDesk regulatory intelligence has saved us so much time, especially if it’s a region you are not a subject matter expert in. What they provided on the Middle East has been a godsend.”
Forrester also found that improved visibility and reporting alone contributed $794,000 in benefits over three years. By connecting previously siloed systems, RegDesk enabled teams to avoid lost revenue opportunities, eliminate duplicate work, and ensure consistent data across regions.
Real Customer Impact
The study highlights customer voices that bring the data to life.
Centralization and Efficiency
“RegDesk really helped us centralize, standardize, and make our data globally accessible. Everything is in one place, standardized, and can be analyzed consistently.”
Dental Devices
Teams reported being able to reuse FDA and EU submissions for other markets, drastically reducing the time and effort to prepare new applications. A single submission that previously took 105 hours across multiple teams could now be completed in a fraction of the time.
Improved Collaboration and Visibility
“It’s been a central platform that we can use as a team in a cohesive manner.”
Dental Devices
By moving to RegDesk’s cloud-based RIMS, organizations gained a single source of truth for global registrations, reducing searching time from weeks to hours.
Implementation and IT Benefits
“[During implementation] RegDesk provided templates, guided us through the process, and it went really smoothly, from start to finish.”
Dental Devices
IT teams also benefited from continuous validation and SOC 2 compliance, saving time and ensuring audit readiness without additional overhead.
Customer Service and Partnership
““What separates RegDesk from other regulatory intelligence systems is their customer service. They are so good at customer service. They really listen to our requests, and the training they provide is above and beyond any other software provider I’ve worked with.”
Healthcare
Beyond technology, RegDesk’s collaborative approach and regulatory expertise were repeatedly cited as key differentiators in the Forrester interviews.
How These Findings Translate into Action
For regulatory and quality leaders, these findings offer a clear roadmap for transformation.
- Quantify your ROI
Use Forrester’s benchmarks (196% ROI, 6-month payback) as a baseline to evaluate your potential impact.
- Identify efficiency gaps
Track where manual processes slow down planning, submissions, or compliance. RegDesk’s automation and centralized intelligence directly address those bottlenecks.
- Accelerate global market access
By reusing submission templates and gaining real-time visibility, teams can launch products faster in more markets.
- Reduce risk exposure
With consistent data and compliance tracking, organizations can avoid costly errors and ensure regulatory alignment worldwide.
Ultimately, the study underscores a mindset shift: regulatory operations are no longer just about compliance, they’re about strategic enablement and business growth.
Conclusion
The Forrester TEI study makes it clear: modernizing regulatory operations pays off fast. With RegDesk, organizations gain measurable financial returns, save thousands of hours per year, and empower teams with real-time visibility across global markets.
In a field where accuracy, speed, and collaboration directly influence market success, RegDesk stands out as more than a RIMS, it’s a partner in accelerating innovation and reducing compliance risk.
Independent Forrester research found that RegDesk delivers 196% ROI, $2.6M in value, and payback in under six months. The evidence speaks for itself.
