Electronic Submissions Consulting

As Regulatory Agencies mandate the use of electronic submissions in eCTD format, development of best practices and industry insight are imperative. Through the use of our eCTD Readiness Assessment and our extensive knowledge of eCTD requirements and guidelines, our team provides consultation to ensure a streamlined, end-to-end submission process.

At TruSubmit, we offer strategic guidance for businesses looking to initiate or transition current publishing operations to electronic submissions. Our service offerings include:

  • Establish a Quality System to ensure efficient processes and compliant eSubmissions or streamline existing eSubmissions processes
  • Assist with lifecycle management approaches
  • Enrollment and management of ESG (FDA) and eSubmission Gateway (EMA)
  • Institute eCTD compliant document templates for authoring electronic documents
  • Assembly of Clinical Study Reports (CSR) or other key document collections to comply with eCTD standards

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