Converting DMF III into eCTD (Electronic Common Technical Document)

paulag

Involved In Discussions
#1
Dear Regulatories,

as you all know, FDA will only accept DMF submission in eCTD format soon. Working with a contract manufacturer of medical devices, we also have filed some DMFs Type III, but no drug filing .

Can anyone please provide guidance on how to convert DMF information into eCTD? Help needen on both aspects:
- technical - do I simply scan documents and send them as pdfs?
- administrative - which topic of the DMF belongs to which eCTD chapter, and how do I fill the ones that do not apply?

Thanks a lot!:rolleyes:
 
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paulag

Involved In Discussions
#5
Wondering if anyone can recommend an ectd Publishing tool with the right performance for a company only planning to submit a couple of DMFs Type III?
 
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