FDA Grants Breakthrough Designation to Amgen’s Cancer Antibody Drug
The U.S. Food and Drug Administration (FDA) awarded Amgen's cancer antibody drug, bemarituzumab, Breakthrough Therapy Designation for a first-line treatment for specific kinds of gastric cancer. The decision comes after the FDA reviewed data from Phase II FIGHT study...
The Importance of Patient Diversity: Asian Americans and Diabetes
Patient centricity and patient diversity are two trends that have taken the life science sector by storm. Simply put, patient centricity is defined as “designing a treatment, clinical trial, or other health solution centered around the patient”. Patient diversity, on...
LATAM Series: Brazil’s Medical Device Regulatory Pathway
Latin America (LATAM) is a diverse region, with over 650 million people spread across 20 different countries, each with their own culture and unique history. For medical device companies, LATAM is a promising market, with its current value estimated to be $11 billion...
COA Translations: Empowering the Voice of Patients of Diverse Backgrounds
Over the last several years, patient-centricity has been a key theme in the healthcare sphere for improving drug therapies and medical devices for patients all around the world. To better serve patients, life science companies are putting in more effort on listening...
Translating TMFs for Global Clinical Trials
There is no doubt that clinical trials are vitally important in the drug development process. As an increasing number of clinical trials are conducted overseas, sometimes with multiple ongoing studies at once, having in-depth knowledge...
Ensuring Biocompatibility for Medical Devices
There is no doubt that medical devices are vital tools that not only enhance quality of life, but also save lives. From invitro diagnostic devices (IVD) like HIV blood diagnostic tests and blood glucose self-testing to software as a medical device (SaMD) that have...
The Importance of Quality Translation for the 2021 EU MDR Deadline
On May 26th 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced and fully covered by the Medical Device Regulation (MDR). Since the original medical device directive’s...
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CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com