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.

Nuestros servicios

Expertos en serialización

Nuestro servicio de Expertos en Serialización ofrece soporte ágil, especializado y multilingüe, diseñado para garantizar la continuidad del negocio en todas las operaciones de serialización. Asegure el cumplimiento normativo y el funcionamiento sin interrupciones con soluciones técnicas completas y un equipo de soporte altamente cualificado.

Validación de sistemas
y calificación de equipos

Maximiza el rendimiento de tus sistemas con la experiencia de Nubinno en validación de sistemas y calificación de equipos, adaptada a las necesidades específicas de tu negocio farmacéutico.

Implementación e integración de sistemas

En Nubinno, nos especializamos en la implementación e integración de sistemas, actuando como tu socio de confianza para optimizar procesos y garantizar que tus sistemas funcionen de forma cohesionada, eficiente y en cumplimiento con la normativa.

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