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.
CSOFT Health Sciences Dreams of the Future in a New Trailer for the 2023 Summer Soiree
Last week we shared a brief teaser for the CSOFT Summer Soiree and its centerpiece game, The Shape of Things to Come, where we’ll be asking our guests to submit a prediction about what will occur in the next six years, be it for the Health Sciences or another...
Watch CSOFT’s Teaser Video for Our Summer Soiree!
CSOFT Health Sciences will hold its 2023 Summer Soiree at the Harvard Art Museums in just a few short weeks. We’ve chosen this specific location to bring the worlds of art, communication, and science together in one venue so that we may, like those gathered at DIA...
CSOFT Health Sciences Heads to DIA 2023, Illuminating Opportunities to Drive Diversity in Clinical Trials
As summer arrives in New England, we are excited to announce CSOFT Health Sciences will be returning as exhibitors to the DIA 2023 Global Annual Meeting in our home city of Boston, Massachusetts this June 25th-29th! With our extended team in town for the occasion and...