Free checklist for PDF format specifications for FDA submissions

PDF requirements for US FDA submissions (Free checklist)

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 a lot of documents. And in a lot of different formats: Word, Excel, PowerPoint, text files, image files and many more.

Why is it important to comply with the 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. The documents must be reformatted again afterwards, which also increases the amount of manual work. 

Even though FDA provides some flexibility, these guidelines should be followed in most business cases.

What are the FDA submission requirements for PDF files?

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 specifications. You can find all the FDA PDF formatting specifications in our 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 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 pharma and biotech companies either do these in-house, or have outsourced it. Yet, finalizing PDFs for submissions is still done manually. 

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, submission-ready PDF renditions from your source content. Simultaneously, for FDA, EMA, PMDA or any other health authority. Reducing risk of non-compliance and speeding up time to market. 

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