One of the eCTD publishing services we offer here at ONIX is PDF formatting. This is an essential part of eCTD submission.

We must ensure we follow the industry guidance on PDF (portable document format specifications) to meet the maximum readiness for your submission.

In our blog post "What is an eCTD submission?" we talked about how all life science companies need approval from Regulatory Health Authorities to place their human or veterinary medicinal products or medical devices on the market. For this approval to be granted, the relevant data has to be submitted in an electronic format - an eCTD.

One part of the eCTD is documents to ensure PDF files are compliant. The ICH (International Council for Harmonisation) and other regional regulatory authorities (FDA and EMA) provide best practices and industry guidance to help avoid technical rejection as much as possible.

By adhering to these PDF formatting standards, we ensure our client's PDF files that are part of their eCTD submission are of the highest quality and compliant with the requirements.

ICH eCTD Portable Document Format (PDF) Implementation Guide

You can find the implementation guide from the ICH for PDFs here:

It is based on the ICH M2 Expert Working Group Specification for PDF Formatted Documents and covers:

  • File Size
  • Fonts
  • Page Orientation
  • Page Size and Margin
  • Headers and Footers
  • Image Compression to Reduce File Size
  • Use of Acrobat Plug-Ins

FDA Portable Document (PDF) Specifications

The FDA has also published a technical specifications document for Portable Document Format (PDF) Specifications guiding the industry providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

It offers best practices for tasks such as:

  • Fonts
  • Page Orientation
  • Source of Electronic Documents
  • Optimize for Fast Web View
  • Document Navigation

The EMA: Electronic Exchange of Documents: Electronic File Format

The EMA has a guideline entitled "Electronic Exchange of Documents: Electronic File Format", developed by the VICH Expert Working Group. It covers such areas as:

  • File format specifications for single files and additional specifications for hyperlinked files
  • Best practices, including:
  • File formats
  • Fonts
  • Graphics / Images
  • Bookmarks and hyperlinks

PDF formatting is just one of the eCTD regulatory submission services we offer at ONIX. We can also support clients with:

ONIX have extensive experience in submissions to global Regulatory Health Authorities, keeping up to date with the latest submission requirements and best practices.

Please contact the ONIX team today if you want us to help you with your regulatory submission. You can call us on 01753 257 904 or email us at info@onixls.com.