With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory ...

As part of our continuous global regulatory updates and in case it did not catch your attention, please be reminded on ...

The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic ...

Australia is phasing out eCTD Specification version 3.0 on 30th June 2018. The Therapeutic Goods Administration (TGA) ...

eCTD becomes more and more mandatory in different regions and for various submission types. Soon only the eCTD format ...

The ICH Common Technical Document (CTD) provides a common format for marketing authorization submissions in all ICH ...