TruPharma Serialization Compliance Case Study

This case study outlines TruPharma's journey to achieve compliance with the Drug Supply Chain Security Act (DSCSA) through the implementation of OPTEL's VerifyBrand™ solution. Founded in 2012, TruPharma recognized the need to assess its internal processes in light of evolving regulatory requirements. The company faced challenges due to reliance on third-party serialization services and the need for faster compliance timelines set by trading partners. In late 2023, TruPharma initiated an internal evaluation to identify a suitable serialization solution. The selection process focused on execution speed and validation capabilities. Ultimately, the partnership with OPTEL allowed TruPharma to implement the VerifyBrand™ system within four months, significantly enhancing its serialization management. The results included reduced reliance on external consultants, improved internal capabilities, and successful data exchanges with wholesalers. The case study emphasizes the importance of expert guidance and building internal expertise to navigate regulatory challenges effectively.