Case Study: a European multinational pharmaceutical company achieves 100% right-first-time labeling submissions with Freyr

European Multinational Pharmaceutical Company achieves 100% right-first-time labeling submissions with FREYR

A European multinational pharmaceutical company faced significant challenges managing high-volume ANDA labeling activities for its antibiotic portfolio across the US and Most of the World (MoW) markets. Maintaining regulatory compliance and submission accuracy while handling frequent health authority updates created workload pressure and risked delays. They partnered with Freyr for comprehensive end-to-end labeling support services to streamline these processes.

Freyr implemented a dedicated end-to-end labeling support framework, featuring a structured review process and a submission-ready documentation approach. This solution delivered 100% right-first-time submissions and eliminated all "Refuse to File" instances for the client. Freyr's support significantly improved the company's operational efficiency, reduced internal workload, and strengthened regulatory compliance across all markets.