Why you should update your file format from time to time
In an earlier post we explained the importance of digital preservation and why every company should have a digital preservation strategy. As a company, you want to have a guaranteed access to your business documents, regardless of the type, format or age of the file. In an era where digital technology and software packages are evolving […]
Frequently asked questions on the eCTD format (Part 2)
The electronic submission requirements (CDER/CBER) will apply to the following types of submissions:
Frequently asked questions on the eCTD submission format (Part 1)
This article answers the most frequently asked questions on the electronic common technical document submission format. A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for: review notification or in response to a request for additional information What are the […]
A closer look into the eCTD triangle and its modules
CTD is a well known term in the Life Sciences industry, and stands for Common Technical Document. This internationally agreed format contains a set of specifications developed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Ministry of Health, Labour and Welfare.