eCTD filing

eCTD filing
About eCTD
eCTD (electronic common technical document) is an internationally accepted management method for drug registration and evaluation. It can helps to make the drug application and review more efficiency.
Willingjet has rich experience in doing eCTD filing, and can offer full set of eCTD services including content creation, layout checking and link generation, eCTD publishing, eCTD package validation and submission.


eCTD electronic submission process

Registration data translation - text format adjustment - PDF catalog link creation - eCTD structure creation - external link creation - eCTD overall structure verification - problem repair and inspection - submission for review

eCTD validation

  • Word file check

    Check that the page layout, font size and color, text title, table/figure/attachment title and paragraph meet the application requirements;
  • PDF file creation

    Attribute description (including title filling, clear author, PDF version, file size, quick web view), security, font, initial view, corresponding PDF bookmarks, table of contents, links in the document, check the validity of the links one by one, and ensure that There are no omissions and the destination page jumps correctly to ensure the compliance of all PDF files;
  • eCTD structure fabrication

    According to the specific information of the Tracking Log, use the eCTD publisher to upload the edited files from M1 to M5 to establish an eCTD framework that meets the eCTD requirements. Make cross-file links in the eCTD file structure, perform QC and verification, and check link properties and file properties in batches;
  • eCTD Verification

    Validate a complete set of eCTD application materials according to the Chinese eCTD verification standard, generate a verification report with detailed content and clear structure, which can accurately locate relevant documents or content, and solve and repair the warning and error prompts in the verification report until the standard verification is correct and conforms to the eCTD structure specification. electronic submission of documents.