"By changing our processes and implementing Vault RIM, we've changed the way that all of Regulatory operates." - Helen Donnelly, Head of Regulatory Affairs Systems and Analytics, Mundipharma


  • Deployed a new HA query management process in < 5 weeks
  • Migrated data from multiple environments to improve visibility
  • Reduced manual handoffs by 35% with automated workflows

Mundipharma implemented Veeva Vault RIM to align regulatory operations across 120 local affiliates and two major product portfolios. The fast-growing pharma achieved new levels of efficiency and visibility by unifying regulatory data, content, and processes in a single global system.

Siloed Data and Manual Handoffs

Before implementing Vault RIM, Mundipharma’s regulatory information was stored in multiple systems and trackers for their Rx and Cx portfolios. Regulatory process required time-consuming manual data collection and email exchanges with local affiliates.

RIM Transformation Journey

Mundipharma took multiple steps to ensure the success of their regulatory transformation. The implementation team engaged local affiliates and outsourcing vendors when configuring Vault RIM; their firsthand knowledge of existing pain points was instrumental in reimagining the regulatory process. The team also ran a comprehensive readiness program to prepare end users for a new way of working and set higher expectations for data ownership across the organization.

Streamlined Process with Increased Visibility

Mundipharma went live with Vault Registrations, Vault Submissions, and Vault Submissions Archive in April 2022. The global organization now has a single source of truth for all products and markets, with visibility into every step of the regulatory process. Regulatory uses Vault RIM’s reporting capabilities to make more informed decisions with confidence in the accuracy and completeness of the underlying data.

Mundipharma also achieved measurable increases in regulatory process efficiency. By consolidating and automating information flows in Vault RIM, they’ve reduced manual handoffs by 35 percent. Regulatory expects to capture even more efficiency gains by leveraging new metrics in Vault RIM. For example, Regulatory can use insights into dispatch-to-submission times to make process refinements that accelerate health authority approvals.

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