eCTD Brief: The Deep Dive into Electronic Submissions

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

Read More

FDA has published a new guidance on eCTD 4.0

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

Read More

Drug Master File – Count Down

The FDA deadline on NDA, ANDA, BLA and DMF (paper submissions) is less than 4 weeks away. By 5th of May 2017 the FDA ...

Read More

Information on new Technical Rejection Criteria (FDA) on Study Data

As one of the last actions in 2016 (effective December 17, 2016) the FDA enforced some new criteria that will allow ...

Read More

Electronic Application Forms (eAF) update

Since January 1st 2016, all Submissions to the European Union have to include electronic application forms instead of ...

Read More

European eCTD Module 1 Version 3.0 Finalized

EMA eCTD specifications – General Update In October, EMA has officially released the version 3.0 of the European Module ...

Read More

Subscribe To Our Blog!

Digital Brain Header Large Brain Right

It's time to raise your standard 

Contact Us