Blog & Resources Camargo Blog June 9th, 2009

Electronic Filing of eCTD INDs

As large amount of documentation and data are required in IND submissions, the Electronic Common Technical Document (eCTD) format is a wise choice for the submission of INDs to the FDA. Camargo’s experience with filing INDs in the eCTD format includes a very recent eCTD IND application accepted by the FDA’s Division of Anesthesia, Analgesia & Rheumatology Products (DAARP).

Because submission of eCTD INDs requires an e-CTD software package, keep in mind that several versions are available from different vendors. Although applicants can use many different approaches to filing an eCTD IND, Camargo strategy in filing eCTD INDs involves the following steps:

  1. Documents are written in Microsoft WORD files using templates based on ICH eCTD guidances;
  2. PDF documents created from the WORD documents mentioned above;
  3. The PDF documents are loaded onto an XML backbone
  4. Once finished loading the files, the software validates the XML files including backbone and Study Tagging File against DTD format guidelines and allows the entire application to be exported as a submission.
  5. The resulting document submission can then be burned to a CD. It is important to note that not all CD burner software work may work properly when handling these files.

Get Our Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our solutions or contact us.

Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights