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Localization Lessons from EMA and FDA Submission Failures Global regulatory agencies such as the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and China’s National Medical Products Administration (NMPA) each maintain distinct language, formatting, and documentation requirements for life sciences submissions. While the industry continues to […]

Key Challenges in Regulatory Translation for Global Submissions Accurate and compliant translation is essential for successful regulatory submissions in the life sciences sector. As pharmaceutical, biotech, and medical device companies expand into international markets, they must prepare multilingual dossiers that meet the specific requirements of global regulatory bodies. Each authority—whether the EMA, FDA, PMDA, or […]