Cytiva, a global leader in life sciences and a Danaher operating company, faced a critical turning point following its 2023 portfolio integration. With a regulatory workforce split between a rapidly growing MedTech division and a specialized BioTech team, the organization was challenged with decentralized, localized data management. By implementing Veeva RIM Submissions and Submissions Archive, Cytiva successfully transitioned from dispersed, folder-based workflows to a unified, scalable global system.
Before the rollout, Cytiva’s regulatory landscape was fragmented. Submission activities were handled locally at individual sites without a centralized platform, leading to documents being dispersed across various systems and regions.
Integrating a new portfolio added complexity and grew the MedTech team. In parallel, Cytiva aimed to modernize their manual, folder-based processes as regulatory bodies moved toward electronic standards like eSTAR.
Anna Malinowska, lead regulatory strategist for biologics manufacturing at Cytiva, explained that the initiative required much more than a standard IT project. “It was not just a system rollout, but it was really a business transformation”, said Malinowska.
To align the work of both MedTech and BioTech teams, they utilized value stream mapping—a Danaher business system tool—to map current processes. This exercise highlighted critical gaps and areas for improvement before configuration began.
Data migration posed one of the biggest challenges for the Medical Device team, which managed more than 160 different part codes with associated UDI numbers that had to be imported using bulk uploader tools. Additionally, the team had to shift from submitting 5,000-page PDFs to exporting granular data formats, necessitating clear and continuous communication with their Notified Body to ensure alignment with new expectations.
When it came to implementation, the team prioritized in-person collaboration. As Amanda Parish, senior regulatory affairs specialist at Cytiva, explained, “Face to face is definitely the way to go for this. Remote as a last resort.”
Three in-person workshops with Veeva partners proved essential for aligning stakeholders and resolving technical questions quickly—something remote sessions failed to achieve effectively.
Cytiva also took steps to drive adoption with users who weren’t part of the core project. They developed a comprehensive four-week training plan that included live sessions held twice daily to accommodate global time zones, sandbox access for risk-free hands-on practice, and short video tutorials to supplement written documentation.
With a successful Veeva RIM implementation, Cytiva unified their MedTech and BioTech workflows, creating a single, consistent approach across all regions. The solution provides a centralized repository for regulatory data, eliminating the reliance on SharePoint and local drives. In addition, Cytiva has established a foundation for future scalability, including potential expansions into registration tracking.
By harmonizing processes between MedTech and BioTech divisions, Cytiva provides a powerful case study for other companies looking to integrate their internal regulatory functions more effectively.
To learn more about how leading medtechs are driving operational efficiencies with unified RIM, read this case study on bioMérieux.