Hi,
Each section of the CTD will have a "narrative" that you create using Microsoft word and then if needed the section will also have supporting documents, such as COAs, batch records, GMP certifications, etc, that you summarize in the narrative and to which you create a hyperlink from the narrative to the supporting document. Once finalized the word "narrative" is converted to PDF for your eCTD submission.
For ANDAs you should follow OGD's published ANDA checklist (attached).
If you don't want to author the templates from scratch, many companies will supply you with ANDA narrative templates. There are also many companies that provide software to compile the eCTD submissions. I would do a google search for these companies.
Regards,
Cindy
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Cynthia Katsempris
Director, Regulatory Affairs
Three Bridges NJ
United States
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Original Message:
Sent: 10-Apr-2017 13:29
From: Manal Bandak
Subject: CTD/eCTD format for ANDAs
Hi everyone,
I would like to get an advise on how to create CTD format narrative for ANDA and submit it in CTD/eCTD format. What does it mean to create narrative for ANDA ? Is there any website or online resource or a book that you would recommend to study?
Thanks a lot for your help and thoughts in advance!
Best Regards,
Manal J. Bandak