Services: Electronic Regulatory Submissions
Cato Researchâ€™s goal of ensuring quality regulatory documentation and enabling efficient and expeditious global drug development means staying on the cutting edge of technology. Our in-house publishing software provides Cato with the flexibility to develop all accepted formats for global regulatory submissions. This system 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, allowing our sponsors the ability to use the eCTD format without the need of developing their own submissions pilot
- Implemented the FDAâ€™s Electronic Submission Gateway (ESG) in 2007 for submission of electronic submissions directly to the FDA, resulting in faster filing
- Never received a Refusal to File from FDA
- Implemented the Global Submit REVIEWâ„˘ 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:
- 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 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 â€ścumulative table of contentsâ€ť. 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.
- 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.