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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 […]

How to Choose the Right Language Service Provider for Clinical Trials Conducting clinical trials across multiple countries requires more than regulatory planning and site coordination. Accurate, timely, and compliant translation is essential to ensure patient safety, data integrity, and ethical oversight. From Informed Consent Forms (ICFs) and site agreements to patient diaries and electronic Clinical […]

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 […]

Top Trends in Medical Translation for 2025 What’s shaping the future of life sciences localization? From regulatory harmonization to AI-driven content reuse, discover the trends redefining translation workflows across the healthcare and biopharma sectors. Meeting Global Medical Translation Demands in 2025 As the global life sciences industry faces mounting regulatory complexity, accelerated product cycles, and […]