Australia Set for eCTD Submissions Pilot Program
Jul01

Australia Set for eCTD Submissions Pilot Program

The Australian Therapeutic Goods Administration (TGA) appears ready to proceed with a pilot program that will pave the way for full adoption of eCTD submissions.

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How Technology is Streamlining Regulatory Publishing
Apr16

How Technology is Streamlining Regulatory Publishing

Submission publishers face a number of challenges as they perform the day-to-day tasks associated with compiling and inspecting the quality of an eCTD. Innovations in technology are easing the burden in terms of actions publishers must perform manually. Streamlining publishing tasks saves time, effort, resources and in the end, produces a higher-quality submission. Susceptibility to error is a corollary to the number of labor-intensive, manual actions performed by your publishing team. Manual processes also extend the publishing time frame, induce extra effort and require greater resources for quality assurance.

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Hyperlinking Best Practices: Common Issue in PDF Rendition
Mar25

Hyperlinking Best Practices: Common Issue in PDF Rendition

“When you use Word templates with styles and make use of the MS Word ‘cross-referencing’ option, tables, figures, sections, etc. within a given page all are automatically [linked] to their target destinations. However, when you have the same table cross referenced on the same page four (4) times, after rendition to PDF, you must manually break those three (3) extra links and convert the text from blue to black. Do you have this issue or is your EDMS customized to take care of this automatically?”

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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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