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Free checklist for PDF format specifations for FDA submissions

Validate the technical compliance of your
PDF documents against FDA requirements

After a long R&D process, many of the original source documents for eCTD submissions need to be manually reworked. The whole idea of this manual rework is to retain the key information when creating PDFs from original source documents.

Content preparation for FDA submissions is a complex task. The detailed PDF formatting standards of the FDA often slow down regulatory submissions, and negatively impact speed-to-market.

We created this checklist to help you and your organization understand the checks needed to ensure full content compliance in your FDA submissions.

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FDA PDF formatting checklist how to comply for the FDA PDF requirements - What are the requirements for FDA approval - FDA approval guidelines
FDA approval guidelines for PDF submissions - What are the requirements for FDA approval? - FDA submissions PDF specifications

Webinar recording available:
How to generate compliant PDFs for multiple HAs automatically BEFORE publishing eCTD leafs

Are you getting ready for your next submission?
And interested to simplify and speed up submission content creation?

Generating compliant PDFs for multiple health authorities remains a manual task for many.

Manipulating and finalizing PDFs using desktop tools: embedding fonts, checking hyperlinks, adding ToCs and making sure they comply with FDA and other HA requirements. And repeating this for 100.000s of documents. All this manual work will only increase your time to market.

Today, it does not have to be that way.
You can automatically generate FDA, EMA, PMDA (or other HA compliant) compliant PDF renditions before compiling submissions.

The agenda of our 'How to auto generate compliant PDFs for multipla HAs before publishing stage' webinar.
What is the impact preparing submission content manually for 5 different Health Authorities? 116 steps for only 3 documents.
What are the benefits of generating compliant PDFs earlier before the publishing stage for your submissions?

After watching the recording, you will know how:

  • Submission content preparation can be faster and easier
  • Creating submission-ready renditions can positively impact and speed up your FDA submission readiness
  • The same content can be automatically re-authored for multiple Health Authorities without any user intervention
  • How your peers utilize modern rendering technology to achieve global simultaneous submissions
  • How reducing risk of non-compliance can be achieved by implementing small steps in your existing regulatory submissions process

Keywords:

FDA submissions, eCTD FDA submissions, FDA approval requirements, regulatory submissions, FDA submission process, eCTD, FDA PDF technical compliance, FDA PDF formatting specifications, global simultaneous submissions, document rendering

Frequently Asked Questions

What is DocShifter?

DocShifter is the world’s fastest any-to-PDF converter. This is why many small and large companies choose our software to automatically create technically compliant, submission-ready PDF.

High volume, high quality document conversion, on premises or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

Who is using DocShifter today?

DocShifter is being used by many small and large pharma, biotech, medical device and contract research (CRO) companies.

How does DocShifter speed up the creation of submission-ready PDFs?

DocShifter can use the same source document to generate compliant output to different health authorities simultaneously: FDA, PMDA, EMA, HC, SwissHealth and many more. Because DocShifter does not use any native application such as MS Office, or any Adobe technology, it is able to convert documents significantly more quickly than legacy methods. 


Is DocShifter an eCTD publishing tool?

No, DocShifter is not an eCTD publishing tool. Our software helps you create compliant PDFs. The PDFs are ready to be used in your global submissions.

Compiling the PDFs and structuring them according to eCTD guidelines is not handled by DocShifter.

Which systems can DocShifter connect to?

DocShifter has native integrations with OpenText Documentum, Veeva Vault, Microsoft SharePoint Cloud, Generis CARA, Lorenz Docubridge, File Systems, Dropbox and FTP.

It also supports any other system that allows Web Services API connections, such as IBM Filenet, Box, Alfresco etc.

Can I deploy DocShifter in a cloud environment?

DocShifter can be deployed anywhere: in a private, hybrid or public cloud. Furthermore, deploying DocShifter on Docker/Kubernetes allows for infinite scalability to handle peak loads. 

How about pricing?

DocShifter subscription pricing is server, volume and functionality based. To find out more about pricing, please drop us a note at info@docshifter.com

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