Life Sciences + Health

Leaders in Medical Translation in 250+ Languages

Collaboration Across Borders with Victoria Elegant: A Discussion Around the Next Generation of Medical Affairs

In our third podcast episode, CSOFT CEO Ms. Shunee Yee and special guest Professor Victoria Elegant sat down to discuss the evolution of medical affairs as a specialty and how innovation is shaping the industry’s exciting future.

MACHINE TRANSLATION FOR THE LIFE SCIENCE INDUSTRIES: THE MYTH AND THE TRUTH

Our Newest White Paper explores how the rapid development of AI technology and machine learning have provided the translation industry with new capabilities in machine translation (MT), particularly for the life science sector. Learn about the different kinds of MT as well as its potential benefits and limitations across the life sciences industries in facilitating cheaper and faster turnaround times for translation projects, without sacrificing quality.

LATAM Series: Mexico’s Medical Device Regulatory Pathway

For MedTech companies expanding into Latin America, understanding the diverse market’s regulatory pathways is crucial for obtaining successful approvals for their products. Learn about Mexico’s medical device regulatory pathway, including the vital role of language service providers in ensuring MedTech companies can enter Mexico’s profitable market confidently.

Bristol Myers Opdivo Wins The EC Approval for GEJ Cancer

The European Commmision (EC) has granted Bristol Myers approval for Opdivo (nivolumab) to treat adult esophageal or gastroesophageal junction (GEJ) cancer who have pathologic disease after previous neoadjuvant chemoradiotherapy (CRT).

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, leaders in medical translation, 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

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    501 Boylston Street, 10th Floor
    Boston, MA 02116

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    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.

    Novartis begins Zolgensma study after FDA’s hold lifts
    Novartis begins Zolgensma study after FDA’s hold lifts

    Aiming to expand the use of Zolgensma, Novartis has announced the launch of a new phase three study following the FDA’s decision to remove restrictions and partial clinical trial hold. Novartis plans to evaluate the use of Zolgensma to treat patients (aged 2-18) for...

    Bristol Myers Opdivo Wins The EC Approval for GEJ Cancer
    Bristol Myers Opdivo Wins The EC Approval for GEJ Cancer

    The European Commmision (EC) has granted Bristol Myers approval for Opdivo (nivolumab) to treat adult esophageal or gastroesophageal junction (GEJ) cancer who have pathologic disease after previous neoadjuvant chemoradiotherapy (CRT).  With the approval based on the...

    FDA Approves Eli Lilly COVID-19 Drug Without Remdesivir
    FDA Approves Eli Lilly COVID-19 Drug Without Remdesivir

    Expanding on their emergency authorization from November, the FDA has granted Eli Lilly approval for the use of their COVID-19 drug baricitinib to be taken on its own and not in combination with Gilead's drug remdesivir for patients with COVID-19. With the approval...

    Singapore HSA: SaMD Regulation Guidelines Feedback
    Singapore HSA: SaMD Regulation Guidelines Feedback

    Singapore’s Health Sciences Authority (HSA) is seeking feedback on draft guidelines released on standalone medical mobile applications and qualification of clinical decision support software (CDSS). Based on the International Medical Device Regulators Forum’s (IMDRF)...