Beginning of next May, the use of the Electronic Common Technical Document (eCTD) will become mandatory for new DMFs and commercial INDs, as well as all documents submitted to existing DMFs or INDs (amendments, supplements and reports).
All DMF and IND submissions that are not submitted in eCTD format after this date will be rejected.
This requirement has already been effective in NDA, BLA and ANDA applications for almost a year now. Asphalion has been preparing eCTD submissions for a long time before the mandate came into effect and has extensive experience in the preparation of eCTDs for different types of applications.
Contact us for a successful and smooth conversion and filing of eCTD submissions at [email protected]. We can support you with the Medical/Scientific Writing, eCTD publishing and submission to FDA by Gateway.
