Serialized Packaging for a 30+ Country Product Launch

A top-10 global pharmaceutical company needed to launch a new oral solid dose product simultaneously across more than 30 markets, each with unique serialization, labeling, and regulatory requirements. The scope encompassed dozens of country-specific packaging configurations, multiple serialization standards, and a compressed timeline that left no room for error.

The company’s previous packaging partner had been unable to manage the complexity of multi-market serialization compliance, leading to delays and regulatory risk. They needed a contract packaging partner with the serialization infrastructure, regulatory expertise, and project management capability to execute a launch of this scale.

Meridan deployed its multi-site serialization infrastructure, built on Optel and Systech platforms, to support the full range of serialization standards required across more than 30 countries. Each market’s unique serialization, labeling, and regulatory requirements were mapped and translated into country-specific packaging configurations.

The program encompassed 47 unique SKUs with multi-language labeling, each requiring validated artwork, country-specific regulatory content, and unique serialization data formatting. A dedicated project team of 12 was assigned to the program, managing the coordination between regulatory affairs, artwork development, serialization configuration, and production scheduling.

Over the 18-month program, Meridan executed a phased launch sequence that aligned production schedules with each market’s regulatory approval timeline, ensuring product was packaged and available for distribution as each country’s approval was granted.