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.
Research involving a causal link between COVID-19 and diabetes has surfaced in a study published in The Lancet Diabetes & Endocrinology in March. Researchers gathered results showing people who suffered from COVID-19 were 40% more likely than controls to develop...
Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® Cosmetic Technology in Dermal Resurfacing Procedures
Apyx Medical Corporation, a manufacturer of medical devices and supplies and the innovator of Helium Plasma Technology, marketed and sold as Renuvion® and J-Plasma® in surgical markets, today announced it has received 510(k) clearance from the U.S. Food and Drug...
Verrica Pharmaceuticals has obtained its third Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application for its molluscum contagiosum treatment candidate VP-102. The first CRL was distributed in July 2020 as the FDA...