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Regulatory Translation

Morningside’s Life Sciences division offers comprehensive regulatory translation solutions to help simplify the international compliance process and ensure accurate, on-time submissions. By leveraging our team members’ regulatory backgrounds, Morningside delivers regulatory compliant translations that are linguistically accurate, culturally adapted and meet appropriate formatting requirements. Whether you need to translate dossiers, exhibits, or IFUs, our regulatory translation team includes subject matter experts as well as in-country professionals with expertise in the regulatory laws and linguistic requirements of each target country. We have extensive experience working with regulatory agencies around the world including the FDA, EMA, SFDA, and PMDA. To help you overcome regulatory hurdles, we utilize client-specific glossaries and enhanced CAT tools to ensure consistent terminology and error-free deliverables and provide translations in submission-ready templates and formats. Our team has vast working knowledge and experience with the latest FDA (CTD, eCTD) and EMA (QRD) templates.