eCTD Training

Transitioning your current publishing operations to support electronic submissions can be a daunting task. At TruSubmit, we educate and empower our clients through customized training. Whether your company is just beginning to submit applications electronically or your business possesses an existing level of expertise, our comprehensive seminars and strategic oversight facilitate development of all facets of the submission process.

At TruSubmit, interactive education is considered paramount. Our clients receive high-quality, customized training designed to enable you to implement programs using proven best practices for eCTD development and compilation. We even offer seminars about Regulated Product Submission (RPS) designed to prepare our clients for the transition to this new standard. After completion of training, our clients are able to immediately implement practices and put the information learned into action.

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