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.
Industries We Serve
Who We Are
CSOFT Health Sciences provides end-to-end medical translations for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA.
Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.
The Power of Linguistic Expertise
Right Tools. Right Resources
Tools we use
We use a full range of CAT tools including Trados, MemoQ, Transifex, Smartling, and WordServer and translate all document types, including .ai, .doc, .pdf, .ppt, .xlx, .css, .php, .html, .xml, .mml, .txt, .mpg, .mov, .zip, .psd, and more.
Linguists we hire
Our native in-country subject-matter experts with at least 7 years’ experience go through a rigorous certification process and are guided with customer experience surveys
Methodologies we employ
We employ a full range of customized solutions, including translation memory, glossary and style guides, PLLP, and more.
CSOFT works extensively with medical professionals who are dedicated to prevalent therapeutic areas
Start Your Global Journey
Headquarters
501 Boylston Street, 10th Floor
Boston, MA 02116
Phone
+1-617-263-8950 (US/Europe)
+86-10-5736-6000 (Asia)
The Knowledge Vault
Stay in the know
CSOFT life science blog aims to provide a better understanding of complex diseases, and regulatory policies from conducting experiments to introducing new type of drugs into the market.
Review of Johnson & Johnson’s COVID-19 Vaccine Underway
After finding that the Johnson & Johnson vaccines triggered antibody cell formation to fight COVID-19, the European Medicines Agency (EMA) began to review the drug for emergency use authorization (EUA). Meanwhile, the company’s rivals Moderna and Pfizer have also...
Moderna Requests FDA Emergency Use Authorization for mRNA-1273
Today (11/30) Moderna announced their plans to seek emergency use authorization from the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccine candidate that reported a 94.1% efficacy rate. The study, that evaluated over 30,000 U.S participants, has not...
The Importance of Cross-border Cooperation at an International Event: A Reflection
In such a turbulent year, cooperation across borders pertaining to global health has never been more important. Last week, CSOFT supported panel discussions at the Shenzhen 2020 International BioTech and Health Expo, with CSOFT CEO Shunee Yee joining speakers...
FDA Breakthrough Device List Includes Breast Cancer Treatment
A wide variety of medical technology devices are being more rapidly reviewed and tested for patient use through the U.S. Food and Drug Administration (FDA) Breakthrough Device List. Among the list of innovations are two breast cancer diagnostic tests along...
Essential Tremor Treatment Receives Funding from National Health Service (England)
INSIGHTEC, a global healthcare therapeutics company, has received funding from England’s public healthcare provider for their neurological disorder treatment, one that effects 41 million people globally. The treatment utilized acoustic sound energy, a trademark of...
WHO Declares Gilead’s COVID-19 Fighting Drug Ineffective
After an expert panel review of Gilead’s Remdesivir, no evidence was found that it was effective in treating COVID-19. In October, the U.S. Food and Drug Administration (FDA) granted the drug approval for usage in hospitals, and after rescinding the approval, Gilead...
