DSCSA for Manufacturers
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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.
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…
FDA Issues Long-Awaited Grandfathering Guidance
Insights into the November 27, 2017, FDA draft guidance around grandfathering product under DSCSA.
FDA Issues Guidance on DSCSA Waivers, Exceptions and Exemptions
In May 2018, the FDA published new DSCSA guidance.
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.
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.
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…
Aggregation: Why is it Such a Hot Topic?
While aggregation isn’t a regulatory requirement in the U.S., understand how the expectations of your wholesale distributor customers may impact your…
Solving the Challenge of Trade Partner Requirements
Find out what happened when a wholesaler turned to TraceLink after getting an unexpected request.
Ahead of the Curve: Wholesalers, Serialization, and Business Value
Learn more about wholesale distributors who have already begun to explore the potential value of serialized data.