Bristol Myers Opdivo Wins The EC Approval for GEJ Cancer
The European Commmision (EC) has granted Bristol Myers approval for Opdivo (nivolumab) to treat adult esophageal or gastroesophageal junction (GEJ) cancer who have pathologic disease after previous neoadjuvant chemoradiotherapy (CRT). With the approval based on the...
LATAM Series: Mexico’s Medical Device Regulatory Pathway
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...
LATAM Series: Argentina’s Medical Device Regulatory Pathway
In our last Latin American series blog post, we introduced the diversity and complexity of the life science market in the region, with specific focus on Brazil’s regulatory body and track for medical devices. This week, continuing with our Latin American series, we...
Extensive Clinicom Interview: ‘Stigma-Eraser’ and Saving Lives
CSOFT Health Sciences sat down with Dr. Nelson M. Handal, President and Chairman of Clinicom, in our newest podcast episode of Coffee & Conversations to discuss the value of Clinicom’s digital assessment tool in enhancing patient care and eliminating misdiagnoses....
Telehealth & Mental Health: COVID-19’s Impact for Global Well-being
Since the COVID-19 outbreak in 2020, there has been a significant rise in cases of mental health issues like stress, depression, and anxiety around the world. In addition to the anxiety surrounding the virus, disruptions in daily lifestyles globally have brought...
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746: Five key questions answered for MedTech Companies
It has been almost four years since the European Commission passed the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 on May 26, 2017. With the new regulation set to be implemented in 2022, medical device manufacturers looking to market their products...
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...
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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