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.
Canada Approves BeiGene BRUKINSA for Mantle Cell Lymphoma
Health Canada has granted BeiGene approval for BRUKINSA (Zanubrutinib) to treat mantle cell lymphoma (MCL) in adults who have already received at least one other prior treatment.
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.
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.
LifeSignals’ LX1550 Multiparameter Remote Monitoring Platform has been granted FDA Class II 510 (K) approval, following recent CE marketing. With the Remote Monitoring Platform, healthtech companies can improve their product and service portfolios and provide...
Health Canada has granted BeiGene approval for BRUKINSA (Zanubrutinib) to treat mantle cell lymphoma (MCL) in adults who have already received at least one other prior treatment. As global, science-driven biotechnology company, BeiGene focuses on improving treatment...
AstraZeneca has been granted FDA approval for its once-weekly diabetes medicine Bydureon (exenatide) to treat children (aged 10-18) with type-2 diabetes. The drug, an injectable suspension, aims to lower blood sugar rates. The approval is based on a late-stage study...
Our LATAM series continues this week with Mexico’s medical device regulatory pathway. In 2019, Mexico’s import medical device market was estimated to be approximately $5.7 billion USD. In 2020, that number increased to $6.5 billion USD. With demand for medical devices...
Merck (also known as MSD outside of North America) and Eisai Inc. announced that the FDA (Food and Drug Administration) has given approval for the combined treatment of Merck’s KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, and Elsai’s LENVIMA (lenvatinib), a...
The FDA (Food and Drug Administration) has given Octapharma USA approval for the first-ever intravenous immunoglobulin, called Octagam 10%, to treat adult dermatomyositis. 10 out of every million people in the US live with Dermatomyositis, a rare, idiopathic...