Savings For The Regulatory Research Team

Evidence and data. Before implementing RegDesk, interviewees said they faced significant challenges in conducting regulatory research, which was often fragmented, time-consuming, and unreliable. The director, regulatory affairs and clinical operations at a dental devices company, described the process as “very tedious,” with regulatory intelligence largely unavailable outside a few core markets.

Research requests were typically initiated by regional RA teams or distributors seeking country-specific intelligence to support market access or compliance planning. These requests were fulfilled by corporate RA research specialists, who relied on scattered sources, such as newsletters, databases, and internal folders, to gather and interpret regulatory information. The director of regulatory affairs and clinical operations at a dental devices company described the time spent on regulatory intelligence research prior to RegDesk as, “I’d say maybe 10 hours a week is about the right estimate.”

This decentralized and manual approach led to inefficiencies or incomplete research, especially when requests involved unfamiliar regions. In many cases, the location of key documents like certificates was unclear, and access to up-to-date regulatory requirements depended heavily on individual initiative rather than a shared system.

After implementing RegDesk, interviewees reported significant time savings, improved visibility, and efficiencies in regulatory research for their organizations due to centralizing and standardizing their regulatory intelligence workflows. Their RA teams gained the ability to monitor global regulatory changes proactively and respond to ad hoc research requests more efficiently. The senior regulatory manager, emerging tech and cybersecurity at a healthcare company noted: “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 … I really love their regulatory intelligence.”

Modeling and assumptions. Based on the interviews, Forrester assumes the following about the composite organization:

• The composite organization’s global RA team includes five corporate RA specialists dedicated to regulatory research.

• After implementing RegDesk, each research specialist saves 10 hours per research application project by accessing centralized regulatory intelligence and reducing back-and-forth communication.

• Each specialist handles an average of two ad hoc research requests per week.

• The fully burdened hourly rate for a research specialist is $45.

Risks. The value of this benefit will vary according to:

• The structure and size of the corporate research team.

• The number, frequency, and complexity of ad hoc research requests.

• The extent to which RegDesk is adopted and integrated across teams and regions.

• The salary rates for research specialists, which are based on skill set, role, and geographic location.

Results. To account for these risks, Forrester adjusted this benefit downward by 5%, yielding a three-year, risk-adjusted total PV (discounted at 10%) of $553,000.

Savings For Regulatory Planning And Product Or Label Change Efficiencies With RegDesk

Evidence and data. Interviewees highlighted three distinct areas of time and cost savings that RegDesk supported: 1) the reuse of the US Food and Drug Administration (FDA) and European Union (EU) submission templates for global filings; 2) faster and more informed regulatory planning for product and label changes; and 3) reduced reliance on costly regional consultants.

• Before using RegDesk, interviewees noted that if they couldn’t locate prior documents, each new market submission required starting from scratch. Regional teams would request documents from HQ, interpret country-specific requirements independently, and coordinate with distributors who lacked regulatory expertise. This led to delays, redundant work, and limited visibility into registration status across markets. The director, regulatory affairs and clinical operations at a dental devices company, reported that their organization took up to 105 hours per application — 75 hours by regional RAs and 30 hours by HQ — spread over months, sometimes even a full year, to complete a single submission.
  Interviewees said that RegDesk gives their global teams centralized access to documentation and templates, enabling them to reuse FDA and EU submissions for other markets. This streamlines collaboration across RA teams and distributors, reduces manual coordination, and accelerates time to submission with clearer requirements.

• Interviewees also said that RegDesk changed how their organizations assess the impact of product and label changes and build regulatory plans. Previously, this required reaching out to multiple stakeholders to determine where a product was registered and what actions were needed. The director, regulatory affairs and clinical operations at a dental devices company, explained: “We reach out to the global regulatory team and ask ‘Is this product registered?’ Or, ‘We’re going to make this change. What impact would this have?’” Interviewees said that RegDesk streamlines this process. The senior regulatory manager, emerging tech and cybersecurity at a healthcare organization, shared: “Just a ballpark for any region [was] 25 to 30 hours before RegDesk. After RegDesk, easily half it, if not more.”
  Interviewees reported saving 3 hours per application simply by having documents readily available in RegDesk, reducing back-and-forth communication and improving distributor coordination. They noted that these efficiencies support faster decision-making, better planning, and reduced risk across global operations.

• Interviewees also noted that RegDesk helped reduce reliance on external regulatory consultants, particularly in regions where local expertise is typically required. A senior regulatory manager, emerging tech and cybersecurity at a healthcare company noted: “[If you don’t have RegDesk] in a region such as the Middle East, you would hire a consultant to help you understand the laws. Depending on the country, a retainer fee could be $15,000 for 30 hours over multiple years.”

Modeling and assumptions. Based on the interviews, Forrester assumes the following about the composite organization:

• The composite organization submits 250 global regulatory applications annually, using FDA and EU documentation as foundational templates for other markets. With RegDesk, it streamlines each submission: HQ regulatory affairs (RA) teams reclaim 20 hours previously spent manually responding to regional inquiries, sharing documents via email, and supporting government requests; regional RA teams save 15 hours through clearer upfront requirements, fewer documentation gaps, and reduced coordination overhead. The overall time per application drops from 105 hours to 80 hours, saving 35 hours per application and enabling faster market access and improved operational agility. As a result of these productivity gains, RA teams and distributors increase their global submission volume by 10% in Years 2 and 3, accelerating product availability across markets.

• The composite organization manages 488 annual regulatory requests related to manufacturing, product specifications, and labeling changes. RegDesk enables the composite’s RA teams to proactively assess country-specific requirements using built-in checklists, aligning regulatory strategy with marketing and production timelines. On average, RA and distributor teams save 20 hours per request, reducing bottlenecks and enhancing cross-functional collaboration.

• By fully integrating RegDesk into the composite organization’s document systems, it eliminates the need for local regulatory consultants across 12 regions. The composite avoids an average consulting retainer of $10,000 per region, freeing up budget for strategic initiatives and innovation.

Risks. The value of this benefit will vary according to:

• The number and type of application templates submitted to the FDA and EU.

• The productivity efficiencies and collaboration of the RA teams globally.

• The level and number of product specification or label changes.

• Country-specific regulatory requirements and their complexity.

• The extent to which RegDesk is adopted and implemented.

• Salary and retainer levels, which differ by skill set and geographic location.

Results. To account for these risks, Forrester adjusted this benefit downward by 15%, yielding a three-year, risk-adjusted total PV (discounted at 10%) of $2.5 million.

Avoided Loss Of Revenue And Reduced Regulatory Effort Due To Improved Visibility And Reporting

Evidence and data. By enhancing visibility into country-specific requirements and regulatory timelines, RegDesk empowered organizations to proactively identify risks before making significant investments. This shift enabled smarter go/no-go decisions and prevented costly missteps.

• Prior to RegDesk, interviewees said their organizations faced substantial financial setbacks due to regulatory intelligence failures. The director, regulatory affairs and clinical operations at a dental devices company, stated that their organization misinterpreted an update to labeling requirements under the more stringent European Medical Device Regulation versus the Medical Device Directive; this resulted in a $200,000 loss after withdrawing a fully developed product from the market and halting shipments to Switzerland.
  Interviewees cited global product recalls as a recurring risk, often triggered by compliance oversights like missing documentation or misunderstood regulatory changes. The average cost per incident was estimated at $100,000, including direct costs and lost revenue. The director of regulatory affairs and clinical operations at a medical devices firm, said that a US recall prevented their company from listing the product on a Certificate of Foreign Government, delaying international registrations and impacting global revenue. They noted: “It was just a misinterpretation as far as when the labeling had to be updated and entered into the market. ... With RegDesk, those types of things would have been avoided.”

• Several interviewees reported wasted effort and sunk costs from initiating registrations without full visibility into requirements. They incurred nonrefundable fees, typically $3,000 per product per country, only to discover missing documentation that invalidated the submission.
  The director of regulatory affairs and clinical operations at a medical devices firm, estimated that estimated that it cost 30 employee hours per misaligned registration, often followed by government feedback requesting items that they could not fulfill. They added: “We’d start working and supporting a product, put money and time toward it, and then realize we needed an item we don’t have. That changes our whole thought process on whether it’s worth pursuing.”
  These inefficiencies were frequent and cumulative, adding up to substantial operational drag. RegDesk’s centralized intelligence, real-time insights, and improved visibility helped interviewees’ organizations eliminate blind spots, make better-informed decisions earlier, reduce risk exposure, and protect revenue streams.

Modeling and assumptions. Based on the interviews, Forrester assumes the following about the composite organization:

• With RegDesk, the composite organization can submit comprehensive, timely applications. This avoids revenue loss due to missed compliance deadlines worth $300,000 per year.

• The composite also avoids revenue loss due to misallocated international registration fees, which is worth $30,000 per year.

• The composite organization avoids at least 10 instances of misaligned applications annually. As a result, the composite avoids spending 45 employee hours per incident on compiling and submitting documentation for registrations that ultimately can’t proceed due to missing or unavailable requirements. With an average fully burdened hourly rate of $55 for a full-time employee (FTE) on the RA team, these time savings are worth $24,750 per year.

Risks. The realization of these benefits will vary according to:

• The level of visibility into application submissions and regulatory processes.

• The number of misinterpreted or misaligned applications.

• The size and scale of product recalls.

• The level of collaboration in global operations.

• The extent to which RegDesk is adopted and implemented.

• Salary levels, which differ by skill set and geographic location.

Results. To account for these risks, Forrester adjusted this benefit downward by 10%, yielding a three-year, risk-adjusted total PV (discounted at 10%) of $794,000.

IT Validation Efficiencies From Submissions

Evidence and data. Interviewees stated that implementing RegDesk led to measurable time savings and operational efficiency for validation and compliance processes.

• Prior to implementing RegDesk, interviewees’ validation processes were laborious, disjointed, and error-prone. They relied on spreadsheets to manage regulatory submissions and product tracking across thousands of stock-keeping units (SKUs). Multiple RA professionals updated a single master file, creating risk and inefficiency. Interviewees told us that thanks to RegDesk’s automated validation workflows and precertified system updates, they eliminated the need for manual spreadsheet-based validation and change tracking. As a result, the IT computer systems validation manager at a dental devices company explained that validation time per change dropped from “three days over an eight-week period … to a couple of hours, total.”

• Interviewees also noted that they used RegDesk to significantly streamline their compliance reviews, especially those tied to audits and patch management. RegDesk pre-validates its own system updates and communicates only the relevant impacts to the customer; internal teams focus solely on changes that affect their specific set-up, rather than analyzing every update across the platform. The IT computer systems validation manager further emphasized that RegDesk “provides the Certificate of Compliance that I can show an auditor,” allowing their team to shift from full validation to simple verification.
  Interviewees said these efficiencies enable their IT teams to maintain audit readiness, reduce risk, and reallocate resources to strategic initiatives.

Modeling and assumptions. Based on the interviews, Forrester assumes the following about the composite organization:

• The composite’s IT team consists of four FTEs who support regulatory systems and compliance infrastructure, including three software validation specialists and one IT administrator. The average fully burdened hourly rate for an IT validation FTE is $60.

• Each member of the composite’s IT team reclaims 30 hours per month, due to RegDesk’s automated validation workflows, precertified updates, and centralized intelligence. This enables them to focus on strategic initiatives, including the continuous improvement of validated systems, proactive patching and automation testing, and accelerating the time to market for new medical device modules and models.

Risks. The realization of this benefit will vary according to:

• The number of SKUs and complexity of legacy systems.

• The IT team’s size, structure, and role distribution.

• The productivity recapture rate.

• The extent to which RegDesk is adopted and implemented.

• Salary levels, which vary by skill set and geographic location.

Results. To account for these risks, Forrester adjusted this benefit downward by 10%, yielding a three-year, risk-adjusted total PV (discounted at 10%) of $135,000.

Unquantified Benefits

Interviewees mentioned the following additional benefits that their organizations experienced but were not able to quantify:

• Improved collaboration. The interviewees noted that RegDesk has become a central platform for aligning corporate and international regulatory teams, replacing fragmented workflows with structured, traceable collaboration. They emphasized the value of a unified system that fosters trust, cohesion, and operational clarity across global teams. The senior regulatory manager, emerging tech and cybersecurity at a healthcare organization noted, “It helps you engage with your distributors in a trusted way.” The senior regulatory affairs specialist at a dental devices company shared, “It’s been a central platform that we can use as a team in a cohesive manner.”

• Greater transparency. The ability to track submissions, manage documents, and communicate through a single interface has elevated transparency and accountability. The director of regulatory and clinical affairs at a medical devices company noted RegDesk’s role in global regulatory execution, commenting “Having it as an organizational tool to align corporate and international teams … is also going to prove valuable.”

• Operational scalability and cross-divisional harmonization. The interviewees’ organizations have used RegDesk to unify regulatory processes across divisions, geographies, and legacy systems. Interviewees noted that the platform’s modular architecture and enterprise-grade integrations support scalable deployment in complex environments. The director of IT for quality and regulatory and validation tech at a global healthcare organization described the transformation: “We can see now. We could not see before.”
  The interviewees noted that this alignment helps their regulatory teams onboard acquired businesses, expand product portfolios, and manage global registrations with confidence, reducing duplication, strengthening governance, and accelerating enterprise wide adoption.

• Improved employee experience and retention. The interviewees also mentioned that the reduction in manual effort and greater clarity with RegDesk has enhanced employee morale and enabled strategic focus. Their teams report greater satisfaction and engagement. The director of IT for quality and regulatory and validation tech at a global healthcare organization shared, “People are so excited … just seeing it makes them happy … it’s giving them a lot better quality of life.” The senior regulatory affairs specialist at a dental device manufacturer added, “It’s just really helpful to have everything in one spot — accessible, viewable, downloadable, and updatable.”
  Interviewees noted that RegDesk’s interface and centralized access to data have created a better work environment; they believed this contributes to stronger retention and a healthier organizational culture.

Flexibility

The value of flexibility is unique to each customer. There are multiple scenarios in which a customer might implement RegDesk and later realize additional uses and business opportunities, including:

• Peace of mind and job satisfaction. The interviewees noted that RegDesk’s automation and traceability features have reduced stress and improved confidence across their regulatory teams. This allows RA professionals to focus on meaningful work with greater peace of mind. The IT computer systems validation manager at a dental devices firm highlighted the platform’s impact on workload and balance, noting, “I only work a 40- to 50-hour work week, not a 60- to 70-hour work week.” The system’s auditability provides assurance and accountability, according to the IT computer systems validation manager at a dental devices company: “There’s a timestamp for everything … you can see who worked on it.” And the senior regulatory affairs specialist at a dental devices firm added, “The frustration of all of that is not there or is reduced.”

• Cultural shift in product development. Interviewees described how RegDesk has helped change their regulatory team’s engagement with product development, moving from reactive support to proactive planning. With faster access to regulatory intelligence, RA professionals are now consulted earlier in the design cycle, enabling smarter decisions and reducing costly rework. Interviewees noted that this shift improves product-market fit and fosters cross-functional collaboration, positioning regulatory affairs as a strategic partner rather than a compliance bottleneck. “It’s influencing cultural change … if you can get the information fast, they’ll come to you more,” explained the senior regulatory manager, emerging tech and cybersecurity at a healthcare organization.