Hyperlinking Impact on the Critical Path to eCTD Submission Deadline

This is Part 2 of a larger article on hyperlinking best practices. To read Part 1, Hyperlinking: Making the Most of Navigation in eCTD Submissions, click here.  Regulatory operations is frequently asked about submission turnaround time once the final document is delivered. The strategies around how documents are authored will often have an impact on accurately answering this question. When authors are writing submission documents and...

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Hyperlinking: Making the Most of Navigation in eCTD Submissions
Feb05

Hyperlinking: Making the Most of Navigation in eCTD Submissions

When authors generate documents intended for electronic submission they use blue-colored font to indicate where a hyperlink should be added to allow the reviewer to easily access the cross-referenced information. Hyperlinks guide the reviewer closer to the source data or supportive information cited in the body of a document. There are a few industry standards with regards to hyperlinking in submissions.

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Hybrid Software and Services Model for eCTD Submissions

Regulatory Publishing is unfortunately not an exact science. Many different factors from different facets of an organization come into play as you prepare your applications for submission. Coordination is a must in organizing and managing the process from start to finish. Using templates to ensure content is written in the proper format, rendering into acceptable PDF documents, compiling them into the appropriate table of contents,...

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