Beginning 5th May 2017, the ESG must be used for eCTD submission sizes of 10 GB or less for NDAs, BLAs, ANDAs and master files.
Beginning 5th May 2018, the ESG must be used for eCTD submission sizes of 10 GB or less for commercial INDs.
So far, submitting through the FDA ESG required registration and fulfilment of an activation process of the account by sending a guidance compliant test submission. However, as of 20th February 2017, ESG will implement a new, more efficient registration process.
ASPHALION has extensive experience in transmitting electronic submissions using eCTD specifications. We can support you with setting up your ESG account as well as managing your FDA submissions.
If you have any questions, please contact us: email@example.com