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Electronic Submissions for Paper People – What Tools Do I Need?

July 16, 2015 | BJ Witkin, Regulatory Publishing Manager | Regulatory Operations

Now that you know what goes in an electronic submission it’s time to talk about the tools you’ll use to create one.

If you’re going to publish electronic submissions within your own organization you’ll need:

  • Word Processor (Microsoft Word or similar)
  • PDF Tool (Adobe Acrobat [not Reader] or similar)
  • eCTD Publishing Tool (Quantum, docuBridge, GlobalSubmit, eCTDXpress, Omnicia, or other)
  • eCTD Validator (usually comes with the tool)
  • eCTD Viewer (Rosetta Phoenix, GlobalSubmit, Aquila Viewer, or other)
  • Electronic Submissions Gateway (ESG) account

Image courtesy of Stuart Miles at FreeDigitalPhotos.net

Next to each type of tool above I’ve tried to provide some common examples used in the industry.

Let’s break these tools down further.

  • Word Processor: The word processor is used to create the content. Most companies use Microsoft Word, although there are other options (even free ones!).

    MS Word offers two big advantages: familiarity and the fact that many other tools (like Acrobat) have add-ins for it.

  • PDF Tool: The tools used to convert your content documents to PDF and manipulate them once they’re in that format.

    Most companies use Adobe Acrobat—and just to be clear, Adobe Reader isn’t sufficient—but there are alternatives if you’re looking to save money.

    It’s important to know that Adobe Acrobat alone generally isn’t sufficient for pharmaceutical publishing purposes if you’re going to publish within your organization (as opposed to outsourcing it). Most publishers use some kind of add-on tool to ensure PDFs meet FDA’s specifications.

    Examples of these tools are ISIToolbox, Acuta PDF Tools, and Debenu PDF Aerialist Pharma.

  • eCTD Publishing Tool: This is the software that produces the folders and XML we talked about in the previous post.

    Which eCTD publishing tool is right for you? That will be determined by your needs, your budget, your publisher’s experience (did I mention you’ll need to hire a publisher?), etc.

    At a basic level these tools all do the same thing; of course, some have added features which may be useful to your company.

    A good eCTD publishing tool represents a pretty significant investment of time (finding the right one, validating it) and money (these tools typically cost tens of thousands of dollars). Many smaller pharma companies find it’s more economical to outsource their publishing.

  • eCTD Validator: Before you submit to FDA (or any agency for that matter), you’ll want to ensure that your submission complies with the agency’s specifications of eCTD. The eCTD Validator tool does this for you.

    Not all tools are created equal. As a rule, we run all our submissions through at least 2 validators and check their results against each other.

  • eCTD Viewer: In my previous post I mentioned that XML is similar to the language used to create web pages (HTML).

    Just as you use a web browser to translate HTML into something that makes sense and is easy to read, you use an eCTD Viewer to translate the folders and XML into something more human-friendly to read and navigate.

Here’s some XML for an initial IND: And here’s how the Viewer displays it:
 xml  viewer
  • ESG Account: In order to submit to FDA you’ll use the agency’s web portal, the ESG.

    Before you can use the ESG you must first set up an account—see our previous post for instructions on how to do just that. The process typically takes 4-6 weeks so allow time for that when you’re planning your transition from paper to electronic.

In my next post I’ll take you behind the scenes and show you an eCTD publishing tool.

Category: Regulatory Operations
Keywords: eCTD publishing tools, eCTD viewer, eCTD validator, Adobe Acrobat, publishing, ESG, electronic submissions gateway

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