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
CAT Tools: Trados, MemoQ, Transifex, Smartling, WordServer
We translate all document types (.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
Methodologies we employ
Customized solutions
Translation Memory
Style Guides & Glossary
PLLP
CSOFT works extensively with medical professionals who are dedicated to prevalent therapeutic areas
- Cardiology
- Dental
- Dermatology
- Gastroenterology
- Genetic Disease
- Hematology
- Hepatology
- Immunology
- Infections
- Neurology
- Oncology
- Orthopedics
Start Your Global Journey
Headquarters
501 Boylston Street, 10th Floor
Boston, MA 02116
Phone
+1-617-263-8950 (US/Europe)
+86-10-5736-6000 (Asia)
The Knowledge Vault
Stay in the know
CSOFT life science blog aims to provide a better understanding of complex diseases, and regulatory policies from conducting experiments to introducing new type of drugs into the market.
Resurgence of COVID-19 Cases in European Cities Causes New Restrictions
In the most recent report from the UK this past week, cases of COVID-19 have doubled to about 6,000 per day. While infections have been on a slow and steady increase in Europe over the last two months, especially in Spain and France, governmental bodies are...
Translating Lay Summaries – Driving Transparency
A study participant participates in a clinical trial, contributing invaluable data to understanding the safety and efficacy profile of a drug. Yet, patients, despite risking their lives by participating in a clinical trial, don’t usually get to know the outcome of the...
Orphazyme Receives Priority Review by FDA for Treatment of Niemann-Pick Disease Type C
Orphazyme, a biotech company based in Denmark, announced today (9/16) that the FDA has accepted its New Drug Application (NDA) for treatment of Niemann-Pick disease Type C. The genetic disease is both rare as well as fatal, with no currently approved...
NICE Reverses Disapproval of AstraZeneca’s Lung Cancer Therapy Tagrisso
The National Institute for Health and Care Excellence (NICE) originally rejected global biopharmaceutical company AstraZeneca’s lung cancer therapy Tagrisso (Osimertinib), but has since decided to reverse its initial decision. NICE initially did not recommend Tagrisso...
FDA Approves Edwards’ Sapien 3 for Cardiac Treatment
Edwards Lifesciences has developed the Sapien 3 transcatheter heart valve which was approved yesterday (9/8) by the U.S. Food and Drug Administration (FDA) for pediatric and adult patients. Transcatheter heart valves is an option for the new patient population...
FDA and NMPA Grant BeyondSpring Breakthrough Therapy Designations for Chemotherapy-Induced Neutropenia Indication
BeyondSpring, a global biopharmaceutical company focusing on immune-oncology therapy treatments for cancer patients, received today (9/8) breakthrough therapy designations (BTD) from the U.S. Food and Drug Administration (FDA) as well as the China National Medical...
