Pharma Serialization DCSCA Readiness

UCB is a multi-national pharmacutical company with locations in Europe and North America. Faced with US FDA Drug Supply Chain Security Act compliance requirements, UCB leadership retained MDB based on our years of experience in drug pedigree and product serialization compliance programs.

MDB provided guidance and program management expertise to establish the UCB DSCSA Serialization Team in alignment with existing serialization efforts underway for European regulations. Our support included guidance on use of GS1 standards, product labeling and serialization track and trace technology platform selection. Finally we retained a full time project manager to help facilitate the serialization team, establish a schedule and milestones to serialization readiness.

Due to MDBs guidance, knowledge sharing and project management expertise, UCBs serialization team was effective in addressing the compliance requirements as well as customer (wholesale distributor) requirements for serialization and product and case labeling. The team was also successful in identifying gaps in current capabilities and successfully selected and implemented a traceability platform.