Who We Are
CSOFT Health Sciences, leaders 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 eCOA documentation including linguistic validation and are capable of supporting CTD/eCTD submissions with the FDA, EMA, and NMPA. Our language and technology supported solutions help to improve patient diversity in clinical trials. 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.
Industries We Serve
We are dedicated to industry-standard knowledge and quality
Helping You Globalize the Right Way
CSOFT’s experienced and dedicated global regulatory submission specialists help companies comply with these demanding multilingual documentation requirements for submissions while providing the highest linguistic quality
We can help you attain the appropriate, accurate, and sustainable compliance required throughout the entire submission process. We ensure our clients receive the necessary certifications to successfully enter emerging markets.
Medical Translation with a Focus on Precision
Our translation solutions are intended for document types relating to every stage of product development life cycle.
Quality in translation is extremely important, but within the life sciences industry, incorrect translations could literally be life threatening. We use industry-standard processes, however, we also offer flexibility for each customer to allow for their companies’ success, no matter the process.
The Knowledge Vault
Stay in the know
For many years, CSOFT has been supporting the life science industries as they continue to grow. We are dedicated to providing the highest-quality services to our clients, while making sure they have access to different policies and up-to-date information. As a medical communications company, we are taking the initiative to promote and increase awareness in the science community and to every individual.
I nuovi eroi al tempo del coronavirus
Il potere risolutivo delle lingue per un problema globale L’improvvisa epidemia del virus 2019-nCoV e le sue drammatiche implicazioni sulla salute globale riflettono uno scenario di crisi in cui la qualità e la forza di una risposta immediata hanno il potere di...