Early Preparations for Your Establishment Registration SPL
Jul09

Early Preparations for Your Establishment Registration SPL

When the conversation turns to Structured Product Labeling (SPL) our first thought is often about Prescribing Information. But as the US FDA and other regulatory bodies modernize review processes, electronic submissions are having an impact across more and more communications. Establishment Registration is one of the more critical SPL submissions and must be submitted annually to the FDA in a narrow window.

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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: 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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Should all Documents in an eCTD have a Table of Contents and Bookmarks?

Most documents in an eCTD submission that have more than four pages of content include a Table of Contents (TOC). When TOCs are present, files are bookmarked to match the TOC. Furthermore, when documents have Lists of Tables and/or Lists of Figures, the documents are bookmarked to match those entries as well. What if documents don’t contain a TOC?  Is it necessary to add one? Not necessarily. Bookmarks can be used to aid reviewers in...

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GlobalSubmit Presents eCTD Essentials in Multiple Cities this October

In recent years eCTD has become the preferred format for regulatory submissions worldwide, and momentum continues to build as mandates take effect in Europe and the United States. Compiling an electronic regulatory submission is a challenging task even for industry veterans who’e worked on multiple projects. Naturally, an organization making the transition from paper to electronic format or compiling a submission for the first...

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Regulatory Publishing Considerations for Literature References

eCTD submissions frequently include literature references that are submitted to support aspects or statements made within the application. The articles that are provided in the submission are typically from scientific or medical journals that have been downloaded by the sponsor from sources such as the publisher or a service provider like Thomson Reuters. Downloaded articles are commonly formatted following a set of standards that do...

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