Document Submission Readiness

A large proportion of the time spent on creating eCTDs, is focused on making the documentation electronically submission (eSubmission) ready. The technical validation of an eCTD considers that the documents are converted to Portal Document Format (PDF) and that the document settings and the navigational items such as table of contents, bookmarks and hyperlinks all are set to the required values. You can either let us do it for you, or we can offer you training in how to prepare the documentation yourself. Considering how to make your documents submission ready is time well spent and should be addressed as early as possible. Establishing consistent standards and instructions that are reflective of the eCTD specifications can be of tremendous value to the authors. When executed efficiently, submission readiness can result in lowering the overall project time thereby producing significant savings in delivering the dossier to the health authorities.

We are available to:

  • Convert word documents into PDF
  • Prepare PDF documents to be submission ready in accordance to ICH and Regional specific requirements e.g. version, bookmarks and hyperlinks
  • Train in requirements for eSubmission ready documentation
  • Split reports according to ICH granularity including bookmarks and links
  • Split Case Report Forms (CRFs) and create bookmark to EU or US requirements
  • Scan documentation only available in paper

Please contact us at contact@pec-services.com to learn how Pharmaceutical eConsulting can start helping you today and in the future.