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.
如何获得巴西医疗器械的市场准入？
拉丁美洲是一个多元化的地区，有超过6.5亿人口，分布在20个不同的国家，每个国家都有自己的文化和独特的历史。对于医疗器械公司来说，拉美是一个前景广阔的市场，目前估值约为110亿美元，而且还在不断增长。在这个极其多样化的地区，巴西是其中最大的国家，约占整个拉美人口的三分之一，因此拿下巴西就获得了拉美最大的市场，利润也相对更可观。然而，在寻求巴西医疗器械监管的合规性时，医疗器械公司需要考虑哪些重要因素呢？ 巴西的监管机构 巴西的监管机构是国家卫生监督局（ANVISA）。与美国的食品和药品管理局（FDA）类似，其目的是： -...
Covid, Ebola, and Typhoid, Oh My!: A Tale of Global Pandemics
This article is part 1 of a mini-series focusing on the progression of global pandemics. This instalment explores the history of past pandemics and how they relate to the current COVID-19 situation. While it may seem that our current Covid self-quarantine has brought...
Héroes en acción
Una solución lingüística para un problema mundial El brote inesperado del Coronavirus de 2019 tiene innumerables implicaciones para la salud mundial, lo que nos sitúa en un escenario de crisis donde la calidad y la capacidad de respuesta inmediata tienen el poder de...