November 16th 2024
Frontier Scientific Solutions has unveiled plans to use a $1.5 billion commitment from a major investor to create a global free trade zone gateway to facilitate the life sciences supply chain using Wilmington International Airport in North Carolina.
Transition From Clinical to Commercial Supply Chain-Regulatory Starting Materials
March 1st 2018The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.
MediLedger to Explore Use of Blockchain for DSCSA Compliance
October 4th 2017Genentech, AmerisourceBergen, and McKesson are providing pharma user requirements for a new project that will evaluate blockchain‘s potential in meeting requirements of the Drug Supply Chain Security Act, and preventing pharmaceutical counterfeiting.