U.S. FDA eCTD Requirements for Drug Master Files (DMFs)

[@cartoondrug9989]

Hello mam can you plz provide me any ctd dossier file sample

[@varshareddy-we3dv]

Hi ..why we need to submit DMF ,where as we already submitting the API snd mfg.data in dossier eCTD .please tell d rational behind that

[@manalsaleh5100]

Can I have pdf of this material?

[@kavyanainita9873]

Where can I find eCTD submission requirements for USA