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May 11 2010

Switching from Paper to eCTD Submissions

CTD Pyramid

Image via Wikipedia

Despite the many advantages of eCTD submissions, many smaller companies may still be reluctant to take the leap.  Concerns over the costs of implementing an eCTD publishing system and the lack of in-house expertise are often the primary stumbling blocks.  However, these concerns shouldn’t prevent you from moving forward.  An experienced partner with a proven track record in eCTD submissions, such as Cato Research, can provide you a cost-effective way to transition to eCTD submissions.  Here are some of the best reasons why you should be switching from paper to eCTD.

Financial Benefits

  • Printing and shipping costs are eliminated as well as the costs of maintaining your own repository of paper copies.
  • Global Strategy: The CTD structure, along with the growing global acceptance of eCTD submissions, means that your application can be submitted in multiple countries with relatively minor changes.
  • eCTD submissions can help reduce review times, increase your response times to Agency requests, and ultimately lead to a faster approval for your product.
  • For smaller companies looking to partner with big pharma, an eCTD IND or marketing application adds value to your product and can speed the transition of a product to a new sponsor.

 

Improved Application Review Process

  • eCTD is the FDA-preferred format.
  • Most FDA reviewers prefer eCTD vs. paper.
  • Submissions can be uploaded to the Electronic Submissions Gateway (ESG) and are available to reviewers within hours.
  • Reviewers no longer have to search through countless paper volumes to determine what changes have been made to an application.  Instead, they can immediately see which sections have been updated and have the ability to review both the old and new versions at the click of a mouse.
  • Thanks to bookmarks and hyperlinks, a reviewer can easily jump to the paper you just cited, the table you just mentioned, or the validation report you just referenced.
  • The eCTD format allows the use of fillable PDF forms and CFR Part 11 compliant electronic signatures, which can further decrease the processing time required upon receipt by the FDA.
  • FDA employees can access the application remotely, allowing reviewers to continue their review regardless of their location and without the hassle of bringing paper volumes along.

Convenience

  • The eCTD dossier becomes the single authoritative regulatory archive for your application.  Every document submitted to the FDA is now located in one place, making it easy to view product history and transfer regulatory knowledge.
  • The entire application can be available on your file storage network, allowing your employees easy 24/7 access from any location.
  • Multiple people can access the same documents at the same time – no more sharing paper volumes or making extra copies.
  • Many documents submitted in an eCTD IND, such as CMC info in module 3 or nonclinical study reports in module 4, can be reused later in an eCTD marketing application.

Tariq Allana, Ph.D. contributed to this post.  Tariq is a Clinical Strategy Scientist at Cato Research and the Associate Director of Business Development.