Skip to content
  • Industries
      • Life Sciences
      • Banking & Insurance
      • Other Industries
  • Solutions

      Life Sciences

      • Submission ready PDF

      Create compliant PDFs for your regulators all around the world.

      • Automated Word Checker and Fixer

      Automatically check and fix Microsoft Word documents for styling and formatting errors.

      • Automated PDF validation

      Check and fix your PDFs to make sure they meet internal and external guidelines.

      • Automated Report Level Publishing

      Create navigation-rich, searchable PDF reports by merging documents into single or multiple PDFs. 

      • PDF/A & TIFF conversion for archiving

      Mass convert all your enterprise files to future-proof file formats such as PDF/A or TIFF.

      • Incoming e-mail converter

      Monitor e-mail inboxes and automatically convert e-mail & attachments to PDF or other formats for correspondence tracking or other purposes.

      • Audio & Video conversion

      Convert your audio and video files to the format of your choice.

      Finance and Other Regulated Industries

      • Enterprise PDF converter

      Centralize the conversion to PDF for your entire organization.

      • PDF/A & TIFF conversion for archiving

      Mass convert all your enterprise files to future-proof file formats such as PDF/A or TIFF.

      • Incoming e-mail converter

      Monitor email inboxes and automatically convert mails and attachments to PDF or other formats.

      • Automated document generation

      Generate repeatable documents by bringing templates and data together. At scale.

      • Legacy document transformation

      Convert old file formats to the latest standard to ensure accessibility and readability of your valuable content.

      • Audio & video conversion

      Convert your audio and video files to the format of your choice.

      • Document conversion services

      A team of experts to help you convert thousands of digital files to another file format. 

  • Platform
      • How does the platform work?
      The basics. Connect all your systems, convert and enrich documents.
      • Maximum scalability
      How we scale to your fluctuating demands.
      • Speed

      Discover what makes DocShifter 10x faster than comparable solutions.

      • Integrations

      See how easy it is to connect to all your enterprise systems.

      • Automated file format recognition

      Discover how DocShifter can save you time with ‘set and forget’. 

      • Supported file formats

      Discover how DocShifter helps reduce dependency on desktop tools by supporting multiple file formats.

      • OCR

      Create searchable, extractable PDFs using our built-in OCR engine.

      • Deployment

      Windows, Linux, Docker. On-premise or in the cloud. You choose.

      • High-availability

      Keep your conversion services up and running at all times.

      • Insights

      See how rendering is used within your organization. Make smarter decisions based on data.

  • Resources
      • Blog & Whitepapers

      Tips & tricks, blogs, checklists or whitepapers on document conversion, digital archiving, eCTD, regulatory submissions and many more. 

      • Product Videos

      See DocShifter in action: animation videos, product explainers, and how-to videos. 

      • Events & Webinars

      Discover our past and future webinars; and see at which events you can meet us virtually, or in person. 

      • Customer Stories

      How are our customers using DocShifter, what benefits do they see, and what do they see about working with us? 

  • Pricing
  • About Us
      • Company & Our History
      • Faces behind DocShifter
      • Partners
      • Customer Support
      • Careers
Search
Close
Contact Us
  • Industries
    • Banking & Insurance
    • Life Sciences
    • Other Industries
  • Solutions
    • Audio & video conversion
    • Automated document generation
    • Automated PDF validation
    • Automated Word checking & fixing
    • Document Conversion Services
    • Enterprise PDF Converter
    • Incoming e-mail converter
    • Legacy document transformation
    • PDF/A & TIFF Conversion For Archiving
    • Report Level Publishing
    • Submission Ready PDF
  • Platform
    • Automated File Format Recognition
    • Deployment
    • High-availability
    • How Does The Platform Work?
    • Insights
    • Integrations
    • Maximum Scalability
    • OCR
    • Speed
    • Supported File Formats
  • Resources
    • Customer Stories
    • Blog & Whitepapers
    • Events
    • Product Videos
  • Pricing
  • About
    • About Us
    • Meet Our Team
    • Partners
    • Careers
  • Contact Us
Menu
  • Industries
    • Banking & Insurance
    • Life Sciences
    • Other Industries
  • Solutions
    • Audio & video conversion
    • Automated document generation
    • Automated PDF validation
    • Automated Word checking & fixing
    • Document Conversion Services
    • Enterprise PDF Converter
    • Incoming e-mail converter
    • Legacy document transformation
    • PDF/A & TIFF Conversion For Archiving
    • Report Level Publishing
    • Submission Ready PDF
  • Platform
    • Automated File Format Recognition
    • Deployment
    • High-availability
    • How Does The Platform Work?
    • Insights
    • Integrations
    • Maximum Scalability
    • OCR
    • Speed
    • Supported File Formats
  • Resources
    • Customer Stories
    • Blog & Whitepapers
    • Events
    • Product Videos
  • Pricing
  • About
    • About Us
    • Meet Our Team
    • Partners
    • Careers
  • Contact Us
Blog

Free checklist for PDF format specifications for FDA submissions

Paul Ireland

  • May 4, 2021

Related Topics

Pharmaceutical and biotechnology companies spend a lot of effort in the R&D process of a new medicine or a product. As every stage must be properly documented, a typical R&D process generates huge quantities of documents. And in a lot of different formats: Word, Excel, PowerPoint, text files, scanned PDFs, image files and many more.

Why is it important to comply with the US FDA PDF submission requirements?

Health authorities base their specific submission content requirements on guidelines. Not complying with these guidelines will increase the risk of refusal to file (RTF) and loss of revenue. In case of technical non-compliance, the documents must be reformatted again, which also increases the amount of manual work. 

Even though FDA provides some flexibility in how the final documents for submissions should be like, these guidelines should be followed in most business cases.

What are the FDA submission requirements for PDF files? (What are the FDA PDF specifications?)

To ensure the PDF is compliant, the original source documents must be prepared in a specific way. The PDF file must be: 

  • Including all content from the original source. 
  • Readable by Adobe Acrobat X. 
  • The correct PDF version (1.4 – 1.7 or PDF/A-1, PDF/A-2)
  • Free from JavaScript or any other dynamic content
  • Free from password or other restrictions. 
  • Embedding all non-standard fonts. 
  • Using font sizes from 9 to 12. 
  • Free from PDF annotations
  • Text searchable if they are scanned. 
  • Optimized for fast web view
  • Including table of contents if they are 5 pages or larger. 

These are just some of the PDF file format specifications for electronic submissions to the FDA. You can find all the FDA PDF formatting specifications in our free checklist. 

Download the free checklist

What is the easiest way to comply with the PDF requirements for US FDA eCTD submissions?

The stringent PDF requirements make US FDA eCTD submissions very complex. Many source documents need to be formatted in a specific way. Hyperlinks, bookmarks, navigation options, table of contents, page margins, PDF versions, annotations, PDF security options, fonts and many more. Manipulating and finalizing all these documents remains a challenging task. 

Many pharmaceutical and biotechnology companies either do these in-house, or have outsourced it. Yet, finalizing PDFs for submissions is still done manually, using desktop tools. Think of PDF plug-ins or macros, for example. 

To save you time and simplify submission-ready PDF generation from source content, we developed the DocShifter software. DocShifter is able to generate fully compliant (high quality, searchable, navigation-rich), submission-ready PDF renditions from your source content. Simultaneously, for FDA, EMA, PMDA or any other health authorities. Reducing risk of non-compliance and speeding up time to market. 

Connect DocShifter with your submission management system(s), and convert original source documents into fully Health Authority compliant PDF renditions. No manual intervention or desktop tools required. Maintain essential quality and compliance, and speed up time to market.

Please take a look in the video to see how you can simplify FDA submission content preparation with DocShifter.

Would you like to schedule a demo with your own (anonymized) content? Happy to arrange that as well. Please pick a day & hour that works for you.

Did you enjoy this blog post? We have more free knowledge-articles available for you. 

Thank you very much for reading our blog post, we hope you enjoyed it.

For more free articles on regulatory topics (eCTD, regulatory submissions, RIM, eCTD v4.0, etc.) we invite you to join our free LinkedIn Regulatory Community.

This community is where we share tips & tricks, updates and learnings on regulatory topics . The community currently has 2000 members and is growing quickly.

In the first 2 editions, we focused on:

  • 4 tips to reduce regulatory content creation issues.

  • The PDF format specifications checklist for FDA submissions.

If you think this is interesting, I would like to personally invite you to join the group. And don’t worry, it is completely free.

Pharmaceutical and biotechnology companies spend a lot of effort in the R&D process of a new medicine or a product. As every stage must be properly documented, a typical R&D process generates huge quantities of documents. And in a lot of different formats: Word, Excel, PowerPoint, text files, scanned PDFs, image files and many more.

Why is it important to comply with the US FDA PDF submission requirements?

Health authorities base their specific submission content requirements on guidelines. Not complying with these guidelines will increase the risk of refusal to file (RTF) and loss of revenue. In case of technical non-compliance, the documents must be reformatted again, which also increases the amount of manual work. 

Even though FDA provides some flexibility in how the final documents for submissions should be like, these guidelines should be followed in most business cases.

What are the FDA submission requirements for PDF files? (What are the FDA PDF specifications?)

To ensure the PDF is compliant, the original source documents must be prepared in a specific way. The PDF file must be: 

  • Including all content from the original source. 
  • Readable by Adobe Acrobat X. 
  • The correct PDF version (1.4 - 1.7 or PDF/A-1, PDF/A-2)
  • Free from JavaScript or any other dynamic content
  • Free from password or other restrictions. 
  • Embedding all non-standard fonts. 
  • Using font sizes from 9 to 12. 
  • Free from PDF annotations
  • Text searchable if they are scanned. 
  • Optimized for fast web view
  • Including table of contents if they are 5 pages or larger. 

These are just some of the PDF file format specifications for electronic submissions to the FDA. You can find all the FDA PDF formatting specifications in our free checklist. 

Download the free checklist

What is the easiest way to comply with the PDF requirements for US FDA eCTD submissions?

The stringent PDF requirements make US FDA eCTD submissions very complex. Many source documents need to be formatted in a specific way. Hyperlinks, bookmarks, navigation options, table of contents, page margins, PDF versions, annotations, PDF security options, fonts and many more. Manipulating and finalizing all these documents remains a challenging task. 

Many pharmaceutical and biotechnology companies either do these in-house, or have outsourced it. Yet, finalizing PDFs for submissions is still done manually, using desktop tools. Think of PDF plug-ins or macros, for example. 

To save you time and simplify submission-ready PDF generation from source content, we developed the DocShifter software. DocShifter is able to generate fully compliant (high quality, searchable, navigation-rich), submission-ready PDF renditions from your source content. Simultaneously, for FDA, EMA, PMDA or any other health authorities. Reducing risk of non-compliance and speeding up time to market. 

Connect DocShifter with your submission management system(s), and convert original source documents into fully Health Authority compliant PDF renditions. No manual intervention or desktop tools required. Maintain essential quality and compliance, and speed up time to market.

Please take a look in the video to see how you can simplify FDA submission content preparation with DocShifter.

Would you like to schedule a demo with your own (anonymized) content? Happy to arrange that as well. Please pick a day & hour that works for you.

Did you enjoy this blog post? We have more free knowledge-articles available for you. 

Thank you very much for reading our blog post, we hope you enjoyed it.

For more free articles on regulatory topics (eCTD, regulatory submissions, RIM, eCTD v4.0, etc.) we invite you to join our free LinkedIn Regulatory Community.

This community is where we share tips & tricks, updates and learnings on regulatory topics . The community currently has 2000 members and is growing quickly.

In the first 2 editions, we focused on:

  • 4 tips to reduce regulatory content creation issues.

  • The PDF format specifications checklist for FDA submissions.

If you think this is interesting, I would like to personally invite you to join the group. And don’t worry, it is completely free.

Related Topics

Loading...
eCTD,Life Sciences,Regulatory operations,Regulatory submissions

Creating the right environment for structured and unstructured data to co-exist

Creating the right environment for structured and unstructured data to co-exist

There’s a lot of talk about structured information and how...
June 30, 2022
Read More
eCTD,Life Sciences,Regulatory operations,Regulatory submissions

A Case Study in Regulatory Operations: Digital Transformation of the Workforce

A Case Study in Regulatory Operations: Digital Transformation of the Workforce

If you work in Regulatory Operations, you are probably knee-deep...
June 15, 2022
Read More
Document transformation services - Easy and fast document conversion services by DocShifter
Document transformation services - Easy and fast document conversion services by DocShifter
Document and PDF Conversion,Enterprise content management,PDFA conversion

What You Should Know About Document Transformation Services

What You Should Know About Document Transformation Services

Mass digital document transformation is one of those things that...
June 7, 2022
Read More
Document rendering solution for regulatory submissions
Document rendering solution for regulatory submissions
Digital archiving,Document and PDF Conversion,Document conversion,Enterprise content management,Life Sciences

What is Document Rendering, and what can it mean for your business?

What is Document Rendering, and what can it mean for your business?

Document rendering is viewed by many as simple document-to-PDF conversion....
April 5, 2022
Read More
What is PDF-A, and how to use PDFA for your digital archive - PDF/A and TIFF conversion for digital archiving - document conversion software
What is PDF-A, and how to use PDFA for your digital archive - PDF/A and TIFF conversion for digital archiving - document conversion software
Digital archiving,Document and PDF Conversion,Enterprise content management,PDFA conversion

What is the PDF/A format, and how to use the PDF/A format for your Digital Archive

What is the PDF/A format, and how to use the PDF/A format for your Digital Archive

Many of us in business and IT set up and...
March 23, 2022
Read More
Life Sciences,Press Release

Pharma time-to-market reduced thanks to more efficient submission document publishing services

Pharma time-to-market reduced thanks to more efficient submission document publishing services

  PharmaLex, a leading provider of specialized services for the...
January 3, 2022
Read More
1 2 3 Next »

Compliant, fast, automated and scalable
file format conversion for the regulated enterprise.

See what our beloved customers have to say about us:

"DocShifter is converting 36.000 documents per day, coming from all over our company (and external). We have no control over what is coming in. And still the failure rate is below 1%.

And what really sets it apart from what we were doing before, DocShifter tells us what went wrong, so we can act upon the documents that did not convert".
Operations Manager Large European Bank
"DocShifter will save us over 750 hours of manual work per year. And we expect the time savings to increase as we continue to expand our use of DocShifter.

This is significant for our clients who need the eCTD sequences to be published quickly, accurately and efficiently. "
Jennie MayDirector, Regulatory Operations - PharmaLex
"Very powerful tool for document conversion and generation. The DocShifter software goes further than our current needs, and from my point of view quite unique in the industry. Quick adaption due to user-friendly workflow creation functionalities. Possibility to create workflows in a user-friendly (non-IT) way. Possibilities for seamlessly integrations into existing solutions."
Kris V.ITS Business Partner, Clinical Development
"We are using DocShifter in conjunction with Documentum software. The rendition performance that is observed so far is more than 4000 documents per hour (on 1 single instance). The output provided is fully compliant to health authority specifications (FDA, EMA, PMDA, HC, SwissHealth, etc.) and is configurable for different countries. A true enterprise document conversion solution.”
Piyush J. Solution Manager
"We use DocShifter to prepare compliant, submission-ready PDF renditions for all regulatory content.

The product is reliable, extremely fast and produces output that is compliant with multiple Health Authorities."
Large US biotechnology companyRegulatory Information Systems Manager
"We implemented DocShifter into production and have converted over 35.000 documents. Our failure rate has dropped from over 10% to well under 0.1%. We have seen an astronomical improvement in our document conversion processes thanks to how easy DocShifter was to implement and to use. In the course of 12 months, we are going to convert more than 100.000 documents with DocShifter. Fantastic document conversion solution!”
Chris B. IT System Administrator - PeopleScout Technology
"We have documentation in different languages, but when converting everything to PDF for submissions, things got complicated really fast. Our rendition engine couldn't cope with all those fonts, and we lost a lot of time fixing problems that weren't supposed to be there in the first place. We decided to make a switch to DocShifter. Scalability during our peak times, ability to deal with multiple fonts, automation (conversion of source documents to simultaneous submission-ready PDFs for multiple health authorities) and performance. These are just some of the things that make DocShifter such a powerful rendering engine."
Jade O. Document Management Professional
"We selected DocShifter for the incredible ease-of-use, the simple configuration and implementation, the high-quality ICH compliant output, and the huge number of formats supported. Performance is excellent, and we reduced the number of rendition servers by a factor of 3. All of this, plus the company’s responsiveness made it an easy choice."
Regulatory Operations & Global Submissions SpecialistLarge pharmaceutical company
"DocShifter powers the document conversion solution in Generis’ new CARA cloud offering. “We already support many joint customers who have advanced document conversion requirements met by the integration of DocShifter with CARA. We are now happy to be able to offer this on a pre-built package with New CARA on our cloud for such customers.”
James KelleherCEO - Generis
"As we are in the middle of a paradigm shift from analogue to digital in Japan, I have been looking for the right solution to support this for many years. In DocShifter we have found a company with solutions that have been selected by organizations of all sizes because of their responsiveness, cost-effectiveness, class-leading performance and unique capabilities that rise above the competition.”
Kosuke OmodaPresident - eSA Japan
"One of the things we love about DocShifter is the graphic interface to configure file transformation flows. The user interface is very simple to use and rare to find within other similar document conversion products. Wide selection of connectors to different solutions (EIM & DMS systems) make DocShifter a great choice for our company as well. We also are very happy with the customer support we receive: extremely friendly and prompt.”
Nikita L.Information Management Consultant
"With DocShifter, we are seeing better performance with even less resources, compared to our previous solution. The deployment is very easy, and the utilization of hardware/software resources are extremely efficient. Thanks to DocShifter's architecture and not needing Office applications, we were able to save a lot of money and resources by the switch.”
Istvan V.Solution Architect
Previous
Next

15 years of experience in automating, simplifying and speeding up document conversion.
For all regulated industries. 

 

 

Rated 5 stars on Gartner’s Capterra platform.

DocShifter document conversion solution is rated 5 starts by our customers on Gartner's Capterra platform.

Contact us

  • hello@docshifter.com
  • +32 (0)9 242 87 39
  • Postal address
    Eedverbondkaai 242/003
    B-9000 Gent
    Belgium
  • Office address
    Kortrijksesteenweg 1144B
    B-9051 Gent
    Belgium

Schedule an intro call

© 2022 DocShifter. All rights reserved.
Privacy policy
Disclaimer
Security

We are using cookies on our website. Cookies that are used, can be viewed in the settings section.

  • Terms and Conditions
  • Privacy Policy
Contact Us
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Strictly Necessary Cookies

Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.