Services: Electronic Regulatory Submissions

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Cato Research’s goals of ensuring quality regulatory documentation and enabling efficient and expeditious global drug development mean staying on the cutting edge of technology. The future of drug development is now, and as of January 1, 2008, the FDA requires that all electronic submissions be in the Electronic Common Technical Document (eCTD) format. Cato Research has recognized this and developed the capability to produce electronic regulatory submissions that conform to the FDA and ICH guidances for this standard.

Cato Research is 21 CFR Part 11 compliant with the handling of electronic documents before their conversion into components of an electronic submission. Our in-house publishing software, provides CATO with the flexibility to develop all accepted formats for global regulatory submissions. The electronic publishing system used for submissions accepts documents in virtually any electronic format for problem-free integration into the eCTD.

Highlights of Experience

  • Received approval from the FDA for the eCTD pilot in 2005. With this pilot in place, it allows our sponsors the ability to use the eCTD format without the need of developing their own submissions pilot.
  • Implemented the FDA’s Electronic Submission Gateway (ESG) in 2007 for submission of electronic submissions directly to the FDA. This results in faster access to your submission.
  • Never received a Refusal to File from FDA.
  • Utilized the Global Submit REVIEW™ software allowing project teams to view eCTD submission just as the FDA will review it.
  • Developed standard eCTD and report templates that streamline the authoring and submission processes.

Electronic Submission Advantages:

Streamlined Review

  • FDA reviewers can receive your submission in a matter of minutes when submitted through the ESG.
  • Electronic documents allow the ability of text searching within and across documents to speed reviews.
  • Hyperlinks and bookmarks allow FDA reviewers to move between various sections of the application quickly and easily.
  • Overall submission quality, organization, and completeness are greatly enhanced by electronic submission.

Lifecycle management

  • Lifecycle management attributes allow electronic applications to grow over time, so that reviewers can always see the most current information. This concept is sometimes referred to as the “cumulative table of contents”. Since the eCTD can accommodate lifecycle management, this concept can be applied to more than marketing applications, but also to INDs, Drug Master Files and other related submissions.

Reduced Cost

  • Physical storage is reduced due to the elimination of hundreds of volumes of paper.
  • The costs of manual labor and equipment to copy and compile submissions is eliminated.
  • The shipping expense is virtually eliminated when the ESG is utilized.

Other Potential Benefits

  • Electronic applications can add value to a program in terms of product licensing potential.