Regulatory Affairs are often the forgotten heroes of business success. It’s easy to celebrate a new product launch or a great financial year but hard to recognize multi-year efforts to compile complex submissions and successfully gain product registrations or the agility required to respond to tens of thousands of compliance questions posed by internal and external customers annually.
The contributions of regulatory affairs professionals are all the more impressive when one considers the disparate, outdated tools they typically have at their disposal to manage complex workflows and high volumes of data and documents.
Specifically, a recent research survey of Regulatory Affairs professionals found that the majority of regulatory departments still rely on emails, siloed spreadsheets, and home-grown systems that are ill-equipped to handle the ever-changing realm of global regulations. The same survey found approximately 90% wanted modern capabilities like dashboards, integrated records, automatic notifications, and a single source of truth for their regulatory documents, data, and processes.
Will business leadership listen and provide regulatory affairs the tools they need to do their jobs more efficiently and effectively? I’m happy to report that more companies are (finally) adopting modern technology to optimize this long-overlooked but critical business area.
Syngenta: Making the Case for Regulatory Modernization
Take, for example, the Swiss-based global AgTech company Syngenta. Like most of its peer companies, prior to 2019, it was managing the complicated regulatory work of its Seeds Division with a patchwork of outdated systems that were extremely labor-intensive, not connected, lacked version control and data validation, and provided virtually no transparency into the status of compliance. Regulatory was seen as a cost center and a source of delays in an already long product development journey.
That all changed when Syngenta decided to implement a cloud-based regulatory management system. The goal was to transition to a technology platform that could provide unified applications and automated processes along every step of the regulatory, safety, and quality management pathways and allow for real-time data analysis. The new system replaced Sparta TrackWise, SmartDoc, Microsoft Excel spreadsheets, SharePoint-based tools, Microsoft Access, GoogleDocs, email, and Extendo PlantOS.
According to Shanna Chriscoe, business lead at Syngenta, moving to a cloud-based unified regulatory management system “allows us to centralize the end-to-end process of registering genetically-modified products, as all of the applications are unified on one platform. Users can now seamlessly exchange information and re-use content. Also, we’ve integrated with Planisware, to reduce data entry duplication, and increase the quality of information across systems,” she commented.
Modern Regulatory System Leads to Significant Visibility and Efficiency Gains
Tiffany Tanner, a Senior Consultant at Veeva and previously the Global Regulatory Operations Manager with Syngenta, remembers the grueling exercise of consulting multiple spreadsheets and applications to generate submissions status reports. Perhaps you can relate?
She provided reports to the global head of the Regulatory Seeds Division, which involved approaching the few people who had access to the portfolio so they could update the necessary information, which was a multi-day activity. Pulling information for the report could take up to a week, during which no one could log in to make any changes. By comparison, the new system can generate those reports in seconds.
Similarly, when the CEO requested reports that would detail which approvals Syngenta was expecting in the next quarter or which ones had occurred in the last quarter, it could take weeks to produce them. That’s because the existing tools lacked the global transparency needed to ensure data were current and accurate. Specifically, there was no way to manage and know what was contained in the dossiers, so the team manually searched each dossier to determine if it contained reports of interest. Now, tailored reports detailing the current registration status of all seeds products are produced almost instantly.
Beyond quick and efficient report generation, a major benefit of the new cloud-based system is the transparency it provides to users and business partners across the product journey. As Chriscoe describes, “Regulatory and Product Safety can see when studies and other dossier components are complete, and when and where they will, or have been, submitted.”
And as part of this effort, documents showing results of toxicology studies for seed safety are stored in the new system and can be pulled into the dossier with a click. Chriscoe explains that previously, the import approval status of a product was only visible to global regulatory managers. Now, regional regulatory and project managers have visibility allowing for better planning for product development and launch. Other benefits include workload prioritization, maintaining global visibility and standards, less time spent performing administrative tasks, and empowering local responsibility through simple point and clicks to configure logic.
Connecting Regulatory Optimization to Business Success
These new functionalities align with current C-Suite thinking about the growing importance of digital solutions to transform how agrochem companies operate, including enabling the free flow of information across the various business units. A report from Deloitte describes these changes in terms of how chemical companies are developing products, how they interact internally and with their customers, and how they strategize their future course of action. In an analysis of issues addressed by chemical CEOs in letters to shareholders, Deloitte found several key themes, including:
- Creating and delivering business growth by realizing higher value from technologies
- Prioritizing innovation and cost savings to realize continuous growth
- Returning business focus to managing product portfolios
These findings underscore the overarching trend that authorities, managers, and executives are no longer willing to wait weeks or even days for insights into what is happening company-wide.
It’s Time to Modernize Your Regulatory Management System
It is increasingly clear that companies that delay modernizing regulatory management systems and other product stewardship business functions are putting their brand reputation and business growth at risk. But there is an alternative. Modernizing a function like regulatory affairs represents a low-cost, low-risk proposition when compared to costly regulatory mistakes, missed product launches, and/or M&A activities to address category expansion and new category entry. With the right tools, regulatory departments have the potential to be agile, transparent, and efficient -- and transform themselves into business growth enablers.
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