About the Client
As a premier UK-based veterinary pharmaceutical manufacturer, this organization specializes in therapeutics for companion animals, equine, and food-producing livestock. Managing a highly regulated and diverse product portfolio, they operate at significant scale through distinct European and U.S. divisions, overseeing operations across multiple international manufacturing plants.
Business Challenges
- Stalled Time-to-Market: Disconnected handoffs between R&D and regional manufacturing delay commercialization, stalling revenue realization for critical new therapeutics.
- Fragmented Master Data & Change Control: Disparate regional systems cause conflicting Bills of Materials and disjointed engineering change orders, risking production against outdated specifications.
- Elevated Compliance & IP Risks: Without a secure, single source of truth, manual data reconciliation increases FDA/EMA audit friction and leaves proprietary pharmaceutical formulations vulnerable.
- Global Operational Blind Spots: Siloed plant data blocks real-time visibility into production and inventory, preventing dynamic resource allocation and driving up supply chain costs.
- Compounding Integration Debt: Fractured digital architectures duplicate IT maintenance costs and limit the enterprise’s ability to scale operations or integrate new acquisitions swiftly.
What We Did
- Architected a Harmonized Digital Core: Bridged operational divides between European and U.S. divisions to agree on a single global standard, integrating Oracle PLM Cloud (PIM) to replace fragmented legacy systems with an authoritative global item master.
- Standardized Global NPI Workflows: Designed and deployed an end-to-end New Product Introduction (NPI) process, centralizing New Item Requests (NIR) to streamline and govern initial item creation across the entire enterprise.
- Executed Data Cleansing & Automated Governance: Mapped and cleansed disjointed legacy records while embedding strict business validations and automated description generation to enforce nomenclature consistency and eliminate duplicates at the source.
- Engineered Controlled Site Activation: Built localized item activation workflows governed by rigid change order protocols and approval matrices, ensuring precise operational control and accountability at the individual plant level.
- Secured GxP Compliance & Commercial Integration: Delivered fully auditable, GxP-validated processes and seamlessly connected the new manufacturing data core directly to commercial operations to accelerate go-to-market execution.
Value Delivered
- Consolidated a Single Source of Truth: Replaced four disparate legacy systems with one authoritative Oracle PIM core, harmonizing global product data to ensure all international plants operate from a unified, accurate record.
- Enabled End-to-End Lifecycle Traceability: Replaced fragmented regional workflows with a standardized global process, delivering continuous, “cradle-to-grave” visibility of every item from initial inception to final commercialization.
- Drastically Reduced Manual Overhead: Eliminated manual data hunting by automating workflow notifications, enabling intuitive searchability, and centralizing critical file access for global engineering and operational teams.
- Enforced Rigorous Process Accountability: Defined clear ownership and rigid approval matrices across all workflow stages, establishing strict governance and eliminating ambiguity in handoffs between R&D, manufacturing, and commercial units.
- De-risked Regulatory Compliance: Automated comprehensive audit histories to seamlessly address stringent CFR Part 11 and GxP requirements, drastically reducing audit friction and securing the pharmaceutical supply chain.