Case Study: Amgen achieves streamlined global regulatory operations with Veeva Systems' Vault RIM

Amgen Transforms Regulatory Operations with Veeva Vault RIM

Amgen, a global biopharma with more than 23,000 employees, faced increasing regulatory complexity as its product portfolio and international footprint grew. Starting in 2016, the company launched a multi-year program to modernize regulatory systems and make submission planning, review, and tracking more efficient.

Amgen implemented Veeva Vault RIM as a single, authoritative global platform, phasing go-lives and capabilities through 2020 (including Vault Submissions Archive). The solution centralizes regulatory data and documents, integrates with other business systems, and gives users end-to-end visibility; combined with extensive change management (200 SMEs and 160 change champions), it improved workflows, sped information access, drove adoption, and established governance for ongoing enhancements and partner onboarding.

Amgen

Dominique Lagrave

Head Global Regulatory Operations