CSOFT Health Sciences
Information
CSOFT Health Sciences, the leader in clinical trial localization, provides AI/ML-enabled medical translation services for all phases of the drug and medical device product lifecycle, from development to post-launch. We also specialize in DCT solutions, linguistic validation, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of MMA, NDA, CTA, and Medical Device Application submissions.
Products and Services
Artificial IntelligenceConsultingRegulatory Document PreparationTranslations
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