ECTD Publishing

In an environment of continually evolving regulations, we provide electronic publishing and lifecycle management services for the Biotechnology, Pharmaceutical, and Medical Device industries worldwide. At TruSubmit, our proven Quality Systems and professional insight allow us to tailor our services on a per client basis; providing your business with innovative solutions to ensure Agency compliance.

We offer a wide array of services for businesses looking to outsource electronic publishing operations. Our service offerings include:

  • eCTD publishing, compilation and validation
  • Conversion of legacy (paper or non-eCTD) submissions to eCTD format
  • Processing alternate submission formats including Non-eCTD electronic Submissions (NeeS), for Sponsors and Agencies that have not transitioned to eCTD
  • Structured Product Labeling (SPL), including Drug Establishment Registration, Drug Listing and Labeler Code Request
  • Transmission of electronic submissions to the FDA via the Electronic Submissions Gateway (ESG) and to EMA via the eSubmissions Gateway

The eCTD format is strongly preferred by FDA reviewers & mandatory by EMA
  • eCTD format will become mandatory by FDA in May of 2017 for BLAs, NDAs, eDMFs and ANDAs and May of 2018 for commercial INDs
  • Start preparing for the transition now
  • The eCTD format is already mandatory for the EMA Centralised Procedure

Exponential increase in Electronic Submissions
  • About 29% of all INDs submitted in 2009 were in eCTD format. By the end of 2013 this percentage grew to almost 70%.
  • In 2009, about 50% of NDAs were submitted in eCTD format. This increased to over 80% by the end of 2013.
  • The submission of ANDAs in eCTD format grew from about 57% in 2009 to almost 80% by the end of 2013.

FDA and Sponsors benefit from the Electronic Submissions Gateway
  • Since 2006, over 2.2 million submissions have been transmitted to the FDA via the ESG
  • Reviewers receive your submission in under 2 hours as compared to about 120 hours when submitted in paper format
  • Reduced costs associated with printing, shipping, processing, tracking and archiving paper submissions