Life Sciences + Health
Leaders in Medical Translation in 250+ Languages
MEDICAL DEVICE MARKET OVERVIEW AND REGULATORY LANDSCAPE IN LATIN AMERICA
Latin America (LATAM) promises to be one of the most profitable markets for clients in the medical device industry. Our new white paper discusses the Latin American market’s medical device industry and regulatory landscape, with particular focus on Brazil, Mexico, Argentina, Colombia, Peru, Chile, and Venezuela.
How Innovative Technology is Reshaping Patient Centric-Communications and the Integrity of Self-Reported Patient Data
As decentralized clinical trials adopt remote patient monitoring, ensuring patient reported data is secured at the point of capture can help ensure the quality of assessments, ultimately reflecting a commitment to patient centricity. Now, a new blockchain-based platform is demonstrating one technology-driven approach that as always will rely on quality multilingual translation support.
Tracking the globalization of clinical trials
The biopharmaceutical landscape is seeing a dramatic transformation relating to the diversification of global markets for clinical trials. Since the climate for conducting clinical trials overseas varies country to country, an important and consistent factor is translation. Navigating the rules and regulations set by governments for clinical trials can be a complex and challenging process that requires detailed and accurate translations to ensure compliance and validity in ever step of the process.
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 certified in ISO 17100:2015, 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.
拉丁美洲是一个多元化的地区，有超过6.5亿人口，分布在20个不同的国家，每个国家都有自己的文化和独特的历史。对于医疗器械公司来说，拉美是一个前景广阔的市场，目前估值约为110亿美元，而且还在不断增长。在这个极其多样化的地区，巴西是其中最大的国家，约占整个拉美人口的三分之一，因此拿下巴西就获得了拉美最大的市场，利润也相对更可观。然而，在寻求巴西医疗器械监管的合规性时，医疗器械公司需要考虑哪些重要因素呢？ 巴西的监管机构 巴西的监管机构是国家卫生监督局（ANVISA）。与美国的食品和药品管理局（FDA）类似，其目的是： -...
This article is part 1 of a mini-series focusing on the progression of global pandemics. This instalment explores the history of past pandemics and how they relate to the current COVID-19 situation. While it may seem that our current Covid self-quarantine has brought...
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