Driving RIM Excellence and Innovation Through a Data-Centric Approach

Sep 26, 2025 | Paul Attridge

To keep pace with evolving health authority (HA) standards, organizations are taking a data-centric approach with unified RIM systems to improve regulatory efficiency and agility. End-to-end RIM systems enable industry leaders to increase data quality, improve process governance, and leverage continuous publishing to accelerate submission delivery. AstraZeneca, for example, has grown to over 15,000 users since going live with Veeva RIM in 2024, with 72% confident using the new system and 76% acknowledging the benefits of a unified solution.

Here are the key initiatives global biopharmas are taking to increase regulatory operational efficiency:

Connecting RIM data across the enterprise

Organizations are recognizing the value of a unified RIM platform to drive enhanced data quality and process excellence. Gedeon Richter implemented Veeva RIM while educating users on the importance of high-quality data and its business impact. “End-to-end data flow is very useful because we are responsible not only for the regulatory activities, but also to ensure other functions within the company get the right information,” said Krisztian Fodor, Gedeon Richter’s head of global regulatory strategy. Within just a couple years from implementation, the company ranked top tier in an industry performance analysis survey.

Roche implemented Active Dossier to consolidate data spanning multiple related entities to ensure data quality is maintained at every level. “Active Dossier consolidates data from across the whole RIM Vault, and this gives us transparency of our data that we have not had before,” said Lynsey Geldeard, regulatory program director at Roche. Improved data and document visibility helps the company efficiently perform change assessments, plan submissions, and support compliance for product batch releases.

Companies are focusing on long-term data management strategies that support cross-functional technology infrastructure and processes. For instance, Novartis has an ongoing initiative to build master data management (MDM) systems that seamlessly integrate product data with Veeva RIM for enterprise-wide data and process alignment.

Accelerating submissions with continuous publishing and quality data

With Veeva Submissions Publishing on a unified RIM platform, organizations can accelerate submissions to deliver medicines to patients faster and with fewer resources. One generics company uses continuous publishing to manage an average of more than 100 daily submissions. Confidently and easily reusing data and documents throughout the entire submission process helps biopharma companies streamline operations. “Efficiency starts by building best-in-class processes which are supported by accurate and standardized data,” said the company’s vice president of regulatory operations.

Alvotech implemented Veeva Submissions Publishing to manage a significantly higher volume of submissions. Within weeks of implementation, the organization submitted post-approval changes and four major biologic license applications (BLAs). When comparing the increase of submission volume from 2020 to 2024, the company saw a 40% increase in efficiency with continuous publishing while using fewer resources.

Driving adoption to strengthen data and process excellence

Every organization will have a different change management strategy when implementing a new RIM system. However, user adoption is key to any organization’s success. As Annalisa Forlenza, Chiesi’s head of global regulatory affairs digital and publishing, points out, “implementation is not just about system deployment. It’s more about having our end users confident, ready, and capable to use the system to get the most from Veeva.” Extensive user support and training on the importance of data ownership and accountability are critical for data quality, especially for key activities such as data entry and data processing.

While external support is valuable, driving change from within the organization is critical for lasting success. Kim Brownrigg, regulatory practice lead for Veeva R&D Business Consulting, emphasizes that “ultimately, change needs to be top down with the right engagement and endorsements” from senior leaders. It must also leverage “the right ambassadors who are going to promote change from within the organization — someone who has lived and breathed the same life as end users.”

After going live with Veeva RIM, AstraZeneca implemented a center of excellence to drive adoption and measure success. For continuous improvement, the company organized a process for addressing user feedback and pain points with actionable change. Jenny Häggström, AstraZeneca’s ERV product manager, explained, “we are here to improve the usability, and the look and feel for end users, to make sure they get the most benefit out of the system.”

To watch key regulatory sessions from this year’s Veeva R&D and Quality Summit, Europe, visit Veeva Connect.