Author Archives: Dan Walles

Serialization: Background, Justification, Requirements, Timelines, and Readiness Across the Supply Chain

Drug manufacturers are facing unprecedented serialization challenges. Serialization requires weighty consideration and focused strategy for successful commercialization, even for those companies that have yet to bring a product to market. The World Health Organization estimates that 10% of medicines worldwide and up to 50% of drugs consumed in developing nations are counterfeit. In response to increasing drug integrity concerns, more than 40 countries have introduced laws mandating serialization and tracing of pharmaceutical products as they pass through the supply chain.…