12-Digit NDC transition
Assess. Prepare. Implement.
Prepare for the FDA’s NDC transformation with Nubinno’s expert support at every stage.
Is your organization ready for the 12-Digit NDC transition?
The FDA’s transition to the 12-digit NDC format requires more than system updates. It demands a clear understanding of how NDC data impacts your products, processes, systems, partners, and compliance activities.
Organizations that start assessing their readiness now will have greater flexibility, lower implementation risk, and a smoother path to compliance.
Nubinno helps pharmaceutical companies assess readiness, identify risks, and build structured transition plans tailored to their organization.
How can Nubinno support your transition?
From readiness assessment to implementation planning, our experts help pharmaceutical companies prepare for the FDA’s 12-digit NDC requirements with confidence.
Our Support Includes:
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- NDC impact assessment
Identify systems, processes, interfaces, and business functions affected by the transition.
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- NDC readiness review
Evaluate your organization’s preparedness and prioritize next steps.
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- Master data assessment
Review NDC, GTIN, and product data structures to identify potential risks.
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- Serialization & GTIN analysis
Assess dependencies between NDC, GTIN generation, serialization, and reporting processes.
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- ERP & system readiness evaluation
Identify field-length limitations, hardcoded logic, and integration risks.
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- Validation & compliance planning
Define testing, validation, and documentation requirements for impacted systems.
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- Trading partner readiness assessment
Evaluate potential risks across CMOs, wholesalers, solution providers, and supply chain partners.
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- Implementation roadmap development
Build a practical transition plan with priorities, milestones, and resource requirements.
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- Risk & business continuity assessment
Identify operational risks and prepare mitigation strategies before implementation begins.
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- Expert advisory & project support
Access experienced serialization consultants throughout your NDC transition journey.
NDC Resources
Discover Nubinno ‘s expert insights on the 12-Digit NDC transition
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