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eCTD Publishing & Submission

The electronic common technical document (eCTD) is the standard format for submitting any applications, amendments, supplements, and reports to the FDA’s Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER).

Understanding eCTD requirements and successfully applying them to your submissions is critical. However, these requirements are not always intuitive, and mistakes (big and small) can occur when documents do not fit seamlessly into the permitted eCTD structure. When this happens, Sponsors can be faced with making last minute changes that can put their submission timelines at risk. Worse still, the entire submission could be bounced back by the FDA which is known as a technical rejection.

Even if you have years of experience with regulatory submissions, small changes in guidances or specifications can have significant repercussions. Prior to starting your submission, you should thoroughly discuss the submission plans. As there are slight differences between eCTD versions, it is also important to discuss the preferred version prior to preparing your application.

Submission Support Services

We offer full-service eCTD submission support including:

  • Compiling and organizing the submission with a standardized submission software
  • Performing quality checks on each document within the submission
  • Ensuring compliance with established electronic document standards
  • Validating the combined submission
  • Uploading the submission via the FDA’s Electronic Submissions Gateway

Throughout the publishing and submission process, we work closely with our clients to ensure that the submission is complete and timely, and that it meets both the client’s and the FDA’s expectations.

Contact us today to learn how we can assist with your next submission.

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