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DSCSA for Manufacturers

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  • futurelink-nashville-noden-pharma-poster.png
    Case Study: Noden Pharma | The Cost of Non-Compliance

    See how global pharmaceuticals company Noden Pharma avoided the financial and operational risks of DSCSA noncompliance.

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  • futurelink-nashville-sharp-poster.png
    Case Study: Sharp Packaging Services | EPCIS Connection Changes Post Go-Live

    See how Sharp Packaging Services overcame EPCIS change management challenges in the pharma supply chain with TraceLink's help.

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  • futurelink-nashville-tracelink-poster-1.png
    Case Study: TraceLink | Building the TraceLink Network One Business Process Ecosystem at a Time

    See how TraceLink's powerful digital supply network enables customers to quickly connect to trade partners for scaling up business process ecosystems.

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  • futurelink-nashville-tracelink-poster-3.png
    Case Study: TraceLink | FDA Pilot - Product Traceability Under 2023 DSCSA Regulations - A Business Process-Led Design for a Blockchain Network

    TraceLink's breakthrough blockchain solution, Trace Histories, can help pharma customers comply with US DSCSA regulations that go into effect in 2023.

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  • futurelink-nashville-tracelink-poster-4.png
    Case Study: TraceLink | Verification Router Service - TraceLink DSCSA Saleable Returns Verification

    TraceLink helps customers meet DSCSA saleable returns verification requirements via the Verification Router Service model. See how.

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  • futurelink-nashville-vdc-poster.png
    Case Study: Value Drug Company | DSCSA Product Investigation—A Compliance Solution

    See how Value Drug Company standardized the process for illegitimate and suspect product investigations for DSCSA compliance.

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    Serialization and Beyond: The Sharp Packaging Story

    The mission of U.S. contract packager Sharp Packaging is to drive the convergence between the physical package and the digital data points as they…

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  • gavel-legal-regulation-optimized-thumb.jpg
    FDA Issues Long-Awaited Grandfathering Guidance

    Insights into the November 27, 2017, FDA draft guidance around grandfathering product under DSCSA.

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  • gavel-legal-regulation-optimized-thumb.jpg
    FDA Issues Guidance on DSCSA Waivers, Exceptions and Exemptions

    In May 2018, the FDA published new DSCSA guidance.

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  • global_regulations_image.jpg
    FDA Announces Enforcement Delay for Manufacturers But Law Still in Effect

    Understand what the announcement means for pharma companies as the November 2017 deadline approaches.

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  • lauren-catalano_tn3.png
    Preparing for EU FMD & DSCSA: The Sharp Packaging Solution Perspective

    Hear Sharp technical executives discuss the similarities and the critical differences between U.S. DSCSA and EU FMD.

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    Saleable Returns: VRS Capabilities and Decision Criteria for Manufacturers

    Learn the criteria for choosing a VRS as the foundation of a saleable returns solution, including network governance, scalability, and…

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