Case Study Life Sciences Quality + Compliance Serialization Implementation: Ensuring Compliance for Product Launch Clarkston Consulting recently supported a clinical-stage immuno-oncology client through ensuring compliance for product launch. Read a synopsis of the project ...
Blog Post Supply Chain Life Sciences How Life Sciences Companies Digitalize Their Supply Chains with TraceLink MINT This piece was written in collaboration with TraceLink. Today’s supply chains have evolved into complex networks demanding greater visibility and ...
Blog Post Quality + Compliance Life Sciences Latest Updates to the Drug Supply Chain Security Act: DSCSA 2024 Deadline Extension The Food and Drug Administration (FDA), in an announcement yesterday, October 9, 2024, is granting exemptions from specific requirements under ...
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 ...
