Sep 23, 2020 | News, Regulatory
With the incoming implementation of the EU Clinical Trial Regulation 536/2014 in December 2021, Parexel, an end-to-end innovative therapeutics solutions provider, has announced the launch of their Regulatory Submissions Hub Service for their life science and... 
Sep 18, 2020 | Machine Translation, Medical Translation, Medical Writing, Regulatory, Terminology
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... 
Apr 24, 2020 | News, Regulatory
In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to Medical Device Regulation by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of...
