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

The implementation process of SPOR over several phases… that’s nothing new. However, after the 6-month delay due to the ...

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 ...

Artificial Intelligence is enabling businesses all over the world to create new value from their existing data. Data ...

Yesterday US FDA has published a new guidance “M4 Organization of the Common Technical Document for the Registration of ...

On June 21, 2017, FDA communicated their intent to ensure that patients are not being priced out of the medicines they ...