Life Sciences + Health

Communication Solutions into 250+ Languages for a Healthier World

The Diversity of India and Its Impact on the Global Clinical Trial Landscape

For global life science companies involved in the drug development process, India’s diversity presents both unique opportunities as well as challenges for innovating new drug therapies.

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.

Abbott Laboratories Announces FDA 510(k) Clearance for Innovative Rapid Handheld Blood Test for Mild TBIs

Abbott Laboratories announced that it received 510(k) clearance from the FDA, making history as the first ever handheld blood test for traumatic brain injuries (TBIs).

Are you looking for an industry outside of the Life Sciences?

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.

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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

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Methodologies we employ

We employ a full range of customized solutions, including translation memory, glossary and style guides, PLLP, and more.

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Start Your Global Journey

Headquarters

501 Boylston Street, 10th Floor
Boston, MA 02116

Phone

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.

FDA Releases AI/ML Five-Part Action Plan for SaMD

The U.S. Food and Drug Administration (FDA) released its artificial intelligence/machine learning five-part action plan for software as a medical device (SaMD). The FDA announced in the plan its intention to create a tailored regulatory framework for SaMD, as well as...