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Insights into the November 27, 2017, FDA draft guidance around grandfathering product under DSCSA.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