As agencies continue to transition to eCTD requirements, Network Partners is ready!
We will help you file compliant electronic submissions worldwide. Our team can help you transition from paper-based submissions, help you file your first electronic submission, or make amendments to your current electronic submissions. We have access to eCTD software and the associated tools to format (including hyperlinking) and publish.
Remember: As of May 5th, 2017 the following submissions were required to be in eCTD format to FDA: NDAs, ANDAs, BLAs. After May 5th, 2018 the following submissions are required to be in eCTD format to FDA: all Commercial INDs, Master Files other than Type III DMFs. As of May 5th, 2019 all Type III DMFs must be filed in eCTD format.
Note: Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received (unless exempt from requirements).