The path to unified RIM: Key attributes driving regulatory excellence
Biopharmas are heavily investing in regulatory transformation initiatives — nearly $3.8 billion over the last five years, according to the 2024 Gens & Associates Report, World Class RIM: Extending the Power of RIM. Organizations achieving regulatory operational excellence have high process maturity, strong data governance practices, high data quality, and business metrics that drive continuous improvement. Adopting a unified regulatory information management (RIM) platform ensures data and process governance, improves cross-team and global transparency, and increases end-to-end submission speed.Building a foundation for unified RIM
The journey to adopting a data-centric approach with a unified RIM platform is different for every company. Large biopharmas must take a methodical approach to break down global silos, simplify complex legacy systems, and streamline ways of working. Emerging biotechs, on the other hand, can take a unified approach from the start but will need to be agile with limited resources to implement and adopt the new solution successfully.
Ensuring that high-quality data is seamlessly maintained and accessible across the business in real-time is core to a unified RIM approach. Accurate, high-quality data has the greatest impact when used effectively across optimized, efficient processes. According to the Gens Report, top performers have an overall 63% high-data-quality confidence rating, compared to 38% for all others. Top performers are also significantly more likely to have dedicated data quality roles, formal regulatory data governance structures such as Centers of Excellence (CoE), and data quality advocates.
Fostering a company culture that drives widespread adoption is also central to maximizing unified RIM value. For many organizations, this may represent a significant change from a traditional functional excellence approach. It often requires end-users to understand and buy into how data, processes, and workstreams impact other teams. Gens reports that 68% of top performers efficiently implement and execute change with a high degree of trust between teams, when compared to everyone else. Similarly, 64% of top performers apply a “right first-time” quality mindset with effective cross-functional collaboration.
Strong company culture also plays a pivotal role in change management, which depends on a clear vision and consistent communication. Companies should consider both push and pull methods for building culture, for example, establishing feedback loops like end-user surveys and providing education on how the overall mission — delivering products to patients with speed — ties to regulatory goals and outcomes.
The value of a unified RIM platform
Nearly 70% of companies are expected to have an end-to-end RIM system strategy in place in the near future, according to the Gens Report. However, the majority of benefits to date have been tactical improvements and risk reduction.
To realize transformative benefits, an end-to-end solution should unify registration tracking, health authority interactions, submission document management, submission publishing, and regulatory submission archiving.
Traditional publishing models require content approval before starting publishing tasks and validation, often just days before the submission is due, increasing the risk of errors and delayed submission timelines.
A key advantage of a unified RIM platform is continuous publishing, enabling the parallel completion of traditional downstream publishing and validation tasks alongside upstream submission planning and authoring. This streamlined approach accelerates end-to-end publishing processes, improving document and messaging quality while readily supporting upcoming requirements like eCTD 4.0 and IDMP. Users can also conduct content review and approval in the context of the eCTD output without waiting until the final step, ultimately getting products to patients faster.
The future promise of unified RIM
A unified RIM platform sets the foundation for future innovation and operational excellence across the business. As a company’s unified RIM strategy matures, it will naturally move from adding core functionality and capabilities to continuous operational improvement and value realization initiatives. By leveraging centralized RIM data and monitoring global requirements, regulatory operations also become a strategic advantage and competitive differentiator for navigating industry change.
According to the Gens Report, strategic initiatives that the highest percentage of companies are working on include 83% improving data quality, 70% simplifying systems and processes, and 63% involving KPI metric programs.
The right unified RIM platform should evolve with changing regulatory requirements, business needs, and technology advancements like AI. When moving to a unified RIM platform, consider these key questions:
Does your organization have the right foundation for a data-centric approach?
Disconnected systems and disparate data models can block future innovation. Getting data right the first time is one of the most important building blocks for successful unified RIM implementation.
Does the platform seamlessly connect to other parts of the organization?
A unified RIM platform maximizes value when connected across the enterprise, improving data and document quality while increasing cross-functional collaboration and global visibility.
Does the platform support continuous improvement?
Cloud-based solutions help companies be agile, responding swiftly to industry changes with three automated releases per year and self-service online publishing training. A change-as-usual mindset combined with fast and easy updates allow biopharmas to keep up with new capabilities and regulations.
Read the full-length e-book and join us at the 2025 Veeva R&D and Quality Summit in Boston to learn more about streamlining regulatory processes, fostering a data-driven culture, and speeding products to market.
Rachel Kelly is senior director of Veeva RIM Strategy at Veeva Systems
