Services Overview

Clinical Trials

Regulatory

Medical & Pharmacovigilance

Nonclinical Safety

Data Management & Biostatistics

Chemistry, Manufacturing and Controls

Medical Writing

Quality Assurance

Project Management

Investigator Registry

Services: Electronic Regulatory Submissions

Cato Research’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 FDA’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 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.