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.

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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
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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.
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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.

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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.

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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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Our references

"Serialization makes drugs safer for patients. Nubinno helped us to register and get ready for serializing of our products for the German market. They also support us with daily challenges of drugs verification from the technical perspective."
Piotr Błaszczyk
Piotr BłaszczykVice – President of the Management Board, Fosun Pharma Sp. z. o. o.
"We absolutely recommend the trainings organized by Nubinno. They delivered the training on how to work with L3 and L4 systems, which was organized in a very professional and clear way and the agenda, as well as the materials were fully customized for us."
Marcin Fajst
Marcin FajstJunior Quality Assurance Specialist/Serialization Coordinator, Celon Pharma S.A.
"Nubinno allows us to promptly solve technical issues on serialization of medicines. It is especially pleasant that technical support is provided in Russian for local colleagues. Thanks to this service, working with serialization has become simple and efficient."
Aliona Zlobina
Aliona ZlobinaCommercial Excellence & SFE manager, EVER Neuro Pharma LLC
"We were having certain challenges with our Russia Serialization operation in the warehouse. Nubinno team came in the short notice and managed to resolve our issues in a timely manner and very effectively."
Alena Andrianova
Alena AndrianovaIT system analytic, Torrent Pharma
“Nubinno provides professional support of our serialization processes and compliance procedures. They helped us to optimize our operations and to get ready for NCA audits and inspections. Nubinno team always goes above and beyond.”
Grzegorz Kaniowski
Grzegorz KaniowskiHead of Serialization, Bioton S.A.
“Nubinno was our partner in preparation of our product serialization. Ever since they are supporting us in daily services of our product serialization environment in a reliable and trustworthy manner.”
Piotr Zaleski
Piotr ZaleskiPharmaceutical Products Office, Łukasiewicz - IChP
“The service provided by Nubinno is over and above what is expected and can be described as exceptional. As a CMO, Siegfried - we thrive and are committed to our core values being Excellence, Passion, Integrity, Quality and Sustainability which can be found within the Nubinno team. This creates the basis for common values, actions and culture providing a firm foundation to ensure success with all customers.”
Mark Dalli
Mark DalliGlobal Coordinator Track & Trace, Siegfried Holding AG
"Nubinno team has helped us at the critical time when we needed to manage our external partner network quickly. Now we have been working with their team for 3 years on continuous support and evolution of our serialization compliance."
Ingrid Lerno
Ingrid LernoQA Manager / Responsible Person GDP

Your partner for global pharma serialization and compliance

From implementation to ongoing support, we provide end-to-end pharma serialization, track and trace, and compliance services (EU FMD, DSCSA). We design, implement, and manage serialization systems for global supply chains, ensuring seamless and compliant operations.

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