Regulatory/Compliance
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Excellis Q&A: Why Phase 3 Manufacturers Shouldn’t Delay Serialization
See how Excellis Health Solutions avoids bottlenecks in serialization implementation, DSCSA challenges, and their philosophy behind phase 3 planning.
What's So Challenging about Continuous Compliance?
In the new regulatory landscape, maintaining compliance is a real challenge.
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.
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Insights into the November 27, 2017, FDA draft guidance around grandfathering product under DSCSA.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.
ACS Q&A: Building a National System for EU FMD
Read an interview with ACS PharmaProtect to learn how the German national system works and how it will operate under EU FMD.
Laetus Q&A: How People, Process, and Planning Will Drive Your EU FMD Compliance Success
Track and Trace Manager at Laetus explains why humans have a major impact on traceability, and what insights supply chain companies can gain from…
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.
Altran Q&A: Spain’s Small Pharmas Face Big Serialization Challenges for EU FMD
Understand the challenges small pharmas face as serialization approaches, and how industry expert Altran helps solve them.
UNITAX Ramps Up Business Growth and Meets Compliance Deadlines Ahead of Time with TraceLink
Learn why UNITAX partnered with TraceLink to help them meet the February 2019 EU FMD serialization deadline ahead of schedule.
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.