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FDA Issues Guidance on DSCSA Waivers, Exceptions and Exemptions
In May 2018, the FDA published new DSCSA guidance.
Minimizing Risk: Prepping for Serialization with Pharmas & CMOs
Pharmaceutical and CMO collaborations will be one of the most challenging aspects of serialization projects. Learn how to prepare together.
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.
What Are the 3 Components of 3PL Serialization?
3PLs will need to upgrade their WMS or go with a solution like TraceLink to support serialization. Find out the other two components 3PLs need.
Hidden Costs of Serialization
Are you prepared to navigate the entire serialization iceberg? View a breakdown of all costs you will incur.
Operational Efficiency Matters: Why Knox Community Hospital Changed DSCSA Solutions
Not all DSCSA compliance solutions are created equally. That’s what Knox Community Hospital discovered the hard way, after struggling with “an…
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.
Poll: 4 of 5 Phase 3s Are Preparing for Serialization Before FDA Approval
Polls show that 82% of clinical-stage virtual pharma companies, uncertain about the impact of serialization, are preparing for DSCSA compliance now.
To Aggregate or Not: 5 Deciding Factors
Here are 5 questions to ask yourself when creating a strategy for serial number aggregation that will set you up for long-term success.
Minimizing Time and Risk with an End-to-End Network
Watch this video to see why traditional point-to-point architecture is not a good fit for new track and trace serialization regulations.
Mutual Drug Discusses DSCSA Compliance Challenges
Hear Mutual Drug discuss their criteria for selecting a DSCSA solution partner plus compliance challenges.
Smarter CMO Onboarding: Speed Up Serialization with Network Efficiency
Learn how a network approach is the best way to boost the efficiencies of CMO onboarding with brand owner customers.