Case Study: Leading Life Sciences Company achieves fully compliant, country-specific clinical labels and improved efficiency with Lionbridge

Regulatory language support to remedy common clinical labeling challenges and improve efficiency

Leading Life Sciences Company, a global provider of drug development, clinical trial logistics, and commercial manufacturing and packaging, needed core text creation (MELT) for a lead neuropsychiatric drug candidate and, later, MELT adaptations and translations for five countries. They engaged Lionbridge to address challenges including clarifying mandatory core-text elements, resolving discrepancies in source materials, adapting content to country-specific regulatory requirements, and implementing timely translation workflows.

Lionbridge collaborated closely with the customer and trial sponsor, using subject-matter experts, targeted investigations, and multi-step translation workflows (forward/back translation and comparative review) plus regulatory validation to produce fully compliant, country-specific labels in English and accurate translations that preserved medical terminology. As a result, Lionbridge delivered labels and translations for five countries on schedule, helped the customer adhere to stringent clinical-labeling standards, quickly troubleshoot issues, and streamline processes by consolidating MELT creation, regulatory validation, and translation services with a single vendor.