The FDA is just one health authority that has made the submission of ANDAs, NDAs, BLAs, DMFs and Commercial INDs in eCTD format mandatory. With paper and non-eCTD submissions no longer accepted across many application types, getting to grips with the efficient preparation of eCTD documents is a must.

To help you on your way to eCTD submission success, we’re here to share our top tips for efficiently preparing your eCTD documents.

Understand the process

The submission process can differ from health authority to authority, a fact that means your current eCTD documents may need to be formatted, structured and/or populated differently to satisfy the latest regulations and requirements.

Understanding the eCTD submission process, therefore, requires careful planning and organisation, particularly when understanding the specifics of a particular submission gateway.

During your application, you should also consider regional requirements as well as regulatory operations best practice to ensure efficient preparation and submission success.

Keep it consistent

Consistency is crucial during eSubmission, especially when it comes to the submission of eCTD metadata. Metadata must be consistent with the format stipulated by the health authority you are submitting your eCTD to. The FDA details how discrepancies in eCTD data can disrupt the entire process:

“Indicating different Submission Type and/or Submission Sub-Type in us-regional.xml and Form 356h could:

  • Impact FDA’s ability to automate the submission process
  • Require additional effort to read the Cover Letter to resolve the discrepancy
  • May require Request(s) for Information that may otherwise not be necessary.”

Complete your application

An application that has missing or incorrectly configured or completed elements will be deemed incomplete. As a rule of thumb, every eCTD document must be error-free and contain all the required information before it can be reviewed and approved.

Call on the experts

Our eCTD submission management and regulatory advisory services ensure you can find the support you need when submitting eCTD documents to FDA, Europe (EMA, MHRA, National Agencies), Swissmedic, Health Canada, TGA and other regulatory health authorities.

We actively support a global client base to make the preparation and submission of eCTD documents as efficient, simple and successful as it should be. We have more than 60 years of combined experience negotiating complex regulatory operational requirements, and use this knowledge to deliver key strategic and technical support to organisations that need it.

Our use of technology, and more specifically our expertise in eCTD MS Word and PDF formatting and automation, means preparation of eCTD documents can be more efficient than ever. We help our clients remove the uncertainty in formatting that plagues many organisations to deliver technically accurate documents that enable regulatory writers to focus on the content within.

For more top tips straight from our experts, please contact us today.