Reduce risk. Ensure quality. Stay compliant.

Expert change management for complex pharma projects.

Change Management

Nubinno change management supports pharmaceutical companies in handling complex serialization changes smoothly and reliably. Whether it’s mergers, acquisitions, CMO integrations, or data migrations, our proven approach keeps projects compliant, well-documented, and on track—without disrupting supply or operations.

End-to-end change management services

With Nubinno change management, pharmaceutical organizations gain a clear framework, defined roles, and consistent quality to manage serialization-related change—reducing risk, safeguarding compliance, and building long-term trust. Our change management service covers the full range of serialization transition scenarios, including:

Transfer of MAH ownership between organizations
Mergers & acquisitions with license consolidation
Divestiture of manufacturing sites with serialization responsibility transitions
CMO integrations and third-party manufacturing alignment
Serialization platform migrations (TraceLink, SAP ATTP, Arvato, etc.)
Regulatory re-registrations and national system integrations (EMVO, CEDM, SFDA)
Vendor switching for MAH/CMO serialization systems

Key Benefits

Compliance assurance — maintain alignment with EMVO, EU FMD, FDA, and other regulatory frameworks.
Business continuity — protect supply chain operations during critical transitions.
Data integrity — ensure accurate master data migration across serialization platforms.
Audit readiness — achieve fully documented, traceable change processes.
Scalable delivery — a standardized model adaptable to acquisitions, divestitures, and vendor switches.

Our services

Serialization
Experts

Serialization Experts Service delivers agile and highly specialized support tailored to ensure business continuity in all serialization operations. Ensure seamless operation and compliance through our dedicated, multilingual support team and comprehensive technical solutions.

System validation and
equipment qualification

Maximize the potential of your systems with Nubinno’s expert System validation and equipment qualification, tailored to meet your specific business needs.

System implementations and integrations

Nubinno specializes in systems implementations and integrations serving as your trusted partner to optimize and ensure your systems work cohesively for a more efficient and compliant operation.

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