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.
Serialization audit
For those who are constantly looking to improve, to identify the gaps and take their serialization and supply chain to the next level. Contact us to find out more on how your processes, people, technology and data stack up against current industry standards.
System integrations and implementations
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.
Market
entry
Unlock global markets with Nubinno Market Entry service, designed to streamline your pharmaceutical product's compliance with serialization and traceability regulations.
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.
Vendor selection for serialization systems
Nubinno specializes in vendor selection for pharmaceutical serialization systems at Level 4–5. Our service helps you identify and evaluate the most suitable solution providers to ensure compliance and transparency across your supply chain.
Change Management
Strengthen your serialization transitions with our change management service, designed to ensure compliance, traceability, and continuity across mergers, acquisitions, and data migrations.
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."
"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."
"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."
"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."
“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.”
“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.”
“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.”
"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."
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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