Regulatory transformation using Veeva Vault RIM for Global Pharma

Overview

A global pharmaceutical leader was struggling with fragmented legacy systems that created compliance risks and operational silos across its regulatory functions. To make a single source of truth and modernize their entire lifecycle, they engaged us for a multi-year, end-to-end transformation program built on the Veeva Vault RIM suite.

RCTL-blog-thumb

Business Challenge

The client is a large, global pharmaceutical organization with complex R&D and commercial operations worldwide. They faced significant challenges due to disparate legacy systems managing regulatory information and processes. This fragmentation led to inefficiencies in planning, tracking, authoring, publishing, and archiving submissions, managing authorized product data, handling HA interactions, and ensuring consistent content management. The lack of a unified system created compliance risks and hindered global collaboration. The client sought a strategic partner with deep Veeva RIM expertise to implement a transformative E2E solution.

Our Approach & Solution

Strategic Program Delivery

Following a multi-release roadmap to systematically roll out capabilities for submissions, product tracking, labelling, and content management to thousands of users globally.

Business Process Transformation

Redesigning and harmonizing core regulatory processes to align with industry best practices and the new platform's capabilities.

Data & Integration Management

Leading data assessment, master data strategy, legacy data migration, and managing complex integrations with other Vaults and external systems.

Business and Community Impact

  • Unified Global Processes: Establishing a single, harmonized end-to-end regulatory process across the entire organization.  
  • A Single Source of Truth: Creating a reliable, centralized system for all regulatory information, dramatically improving data quality and visibility.
  • Enhanced Compliance & Inspection Readiness: Significantly strengthening the client's compliance posture and ensuring they are prepared for regulatory inspections at all times.
  • Improved Cross-Functional Collaboration: Fostering seamless teamwork between HQ, affiliates, R&D, and manufacturing functions through a shared platform.
  • Efficient Health Authority Management: Enabling more effective and transparent management of interactions, submissions, and commitments with global health authorities.