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Terminology Management in Life Sciences

Terminology Management in Life Sciences Ensuring linguistic precision and regulatory consistency across global markets The Role of Terminology in Life Sciences Translation In the highly regulated life sciences industry, accurate and consistent terminology is essential. From clinical trial protocols and regulatory submissions to patient-facing materials and software interfaces, the correct use of terms ensures clarity, […]

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Translating for FDA, EMA, PMDA, and NMPA: Best Practices for Global Regulatory Submissions

Translating for FDA, EMA, PMDA, and NMPA: Best Practices for Global Regulatory Submissions Globalization has transformed the life sciences industry, with pharmaceutical, biotechnology, and medical device companies increasingly seeking simultaneous regulatory approvals across multiple regions. To support these global submissions, accurate and compliant translation of regulatory documents has become a critical component of the approval […]

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Localization Lessons Ema Fda Submission Failures

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 […]

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Ai Mtpe Life Sciences Translation

AI and MTPE in Life Sciences Translation: What Works, What Doesn’t Advancements in artificial intelligence (AI) are transforming how life sciences organizations approach multilingual content. One of the most widely adopted applications is Machine Translation Post-Editing (MTPE), a process where AI-generated translations are reviewed and refined by professional linguists to achieve publication-quality results. In parallel, […]

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Challenges In Regulatory Translation Global Submissions

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 […]

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