Blog Post Supply Chain Life Sciences Emphasizing the Need for U.S. Pharmaceutical Supply Chain Stress Testing: June 2024 PDG-FDA DSCSA Meeting Takeaways Last month, Clarkston serialization experts Michael Marrone and Dave Treadaway attended an open discussion between the Food and Drug Administration ...
Blog Post Supply Chain Life Sciences Navigating the New Phase of DSCSA Interoperability Requirements In November 2023, the Drug Supply Chain Security Act (DSCSA) entered a new phase, focusing on system capabilities ensuring interoperable, ...
Blog Post Life Sciences Supply Chain FDA Announces DSCSA 2023 Deadline Extension The FDA recently announced a one-year delay in enforcing the electronic tracking requirement under the Drug Supply Chain Security Act ...
Blog Post Life Sciences Information Technology Leveraging an Application Managed Services (AMS) Provider for Pharmaceutical Serialization Systems In this blog, we outline the key benefits of leveraging an AMS provider for pharma serialization systems. Since the mid-2000s, ...
Multimedia Consulting Services Biotech Commercial Supply Chain Readiness for Biopharma Organizations For emerging biotech and biopharma organizations, ensuring commercial supply chain readiness is critical to achieving success, and there are key ...
Blog Post Consumer Products Data + Analytics Best Practices in Traceability: Lessons the Food Industry Can Learn from Pharma The pharmaceutical industry has helped lay the foundation for best practices in traceability. As the food industry prepares for enhancements ...
Blog Post Consulting Services Biotech How Will the Verification Routing Service (VRS) Impact DSCSA? Beginning on November 27, 2023, the Food and Drug Administration (FDA) will require wholesalers to verify key identifiers of saleable ...
Blog Post Retail Data + Analytics Understanding the Emerging Demands for Retail Traceability Earlier this year, the New York State Legislature introduced the New York Fashion Sustainability and Social Accountability Act – a ...
Case Study Supply Chain Biotech Serialization and Traceability Registration for a Biopharmaceutical Organization Clarkston has deep and long-standing experience working with pre-commercial life sciences companies, and the challenges of transitioning – and in ...
Blog Post Life Sciences Pharma The Challenge at the Final Mile of DQSA When the Drug Quality and Security Act (DQSA) was passed in 2013, it mandated that full compliance with electronic data ...
Blog Post Life Sciences Pharma The Drug Supply Chain Security Act: Enhancing Security and Traceability The long-awaited final transition of the Drug Supply Chain Security Act (DSCSA) will take effect on November 27, 2023. The ...
Case Study Life Sciences Biotech 3PL and Serialization Vendor Selection for a Biopharmaceutical Company Clarkston Consulting recently partnered with a client for a vendor selection project for 3PL and serialization capabilities. This client is a virtual biopharmaceutical company that focuses on developing ...
