Blog Post Quality + Compliance Life Sciences Ensuring DSCSA Serialization Compliance with AI: Opportunities and Challenges The Drug Supply Chain Security Act (DSCSA) is a federal regulation that was passed by the FDA in 2013 in ...
Case Study Life Sciences Quality + Compliance Supporting a Serialization and Traceability Program for a Biotechnology Company In this serialization and traceability program case study, Clarkston Consulting partnered with a biotech company to implement TraceLink. Read a ...
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 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 ...
Case Study SAP + Technology Supply Chain Global Serialization Track and Trace Implementation Clarkston Consulting recently partnered with a client on a global serialization track and trace implementation. This client company launched a ...
