Life Sciences + Health
Communication Solutions into 250+ Languages for a Healthier World
Medical Device Translation
We provide the highest-quality medical device translation services for life science companies expanding into global markets, from in vitro diagnostic devices and SaMD to Class I, Class II, and Class III medical devices.
Translating TMFs for Global Clinical Trials
TMFs/eTMFs hold crucial clinical technical documentation that demonstrates the study is being conducted following Good Clinical Practices (GCP) guidance. For global clinical trials, TMF translation is a necessity for gaining local regulatory approval.
Medical Device Market Overview and Regulatory Landscape in Asia
In our latest white paper, the Asian medical device market’s landscape and regulatory overview is discussed, with focus on seven major players (China, Japan, Korea, Malaysia, Australia, Thailand and India) and the critical role that language service providers play in the APAC region.
FDA Approves Targeted Treatment for Duchenne Muscular Dystrophy
The U.S. Food and Drug Administration (FDA) approved Amondys 45 (casimersen) injection from Sarepta Therapeutics for the treatment of Duchenne muscular dystrophy (DMD) in patients that have a mutation amenable to skipping exon 45.
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
CSOFT works extensively with medical professionals who are dedicated to prevalent therapeutic areas
Start Your Global Journey
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.
The U.S. Food and Drug Administration (FDA) provided guidance that addresses changes to the supply chain due to COVID-19, including its regulatory process for manufacturing and controls (CMS) and chemistry. Materials like glass vials, stoppers, test swabs, and...
Over the last several years, patient-centricity has been a key theme in the healthcare sphere for improving drug therapies and medical devices for patients all around the world. To better serve patients, life science companies are putting in more effort on listening...
The U.S. Food and Drug Administration (FDA) granted MedAlliance its fourth Breakthrough Device Designation for SELUTION SLR™, a sustained limus release drug-eluting balloon (DEB) catheter, to treat atherosclerotic lesions found in native coronary arteries. MedAlliance...
Boehringer Ingelheim and G1 Therapeutics have announced that the injection of COSELA™ (trilaciclib) is now commercially available in the US. COSELA, the only U.S. Food and Drug Administration (FDA)-approved treatment that is meant to decrease the incidence of...
The U.S. Food and Drug Administration (FDA) approved today NULIBRY™ (fosdenopterin), a treatment developed by BridgeBio and its affiliate Origin Biosciences for molybdenum cofactor deficiency (MoCD) Type A. MOCD Type A is an extremely rare metabolic disorder that...
The U.S. Food and Drug Administration (FDA) cleared Flexion Therapeutics’ Investigational New Drug (IND) application for FX301, a locally administered NaV1.7 inhibitor for post-operative pain. The clearance came after the FDA reviewed preclinical data that was...