10 Small Submissions
No more than 10 Documents per submission
Process to be followed to make an eCTD FDA submission
- Learn about the eCTD requirements
- Review the eCTD submission resources
- Submit fillable forms and compliant PDFs
- Request an application number
- Send a sample submission to the FDA
- Submit via the electronic submission gateway: Industry electronic submissions gateway
Challenges faced in making an FDA eCTD submission
- Requires cutting-edge technology and seasoned staff
- Not all the content is in a standard format. Hence standardization is required
- Difficult to implement last minute changes
- Local affiliates have limited access to create or customize
- Baseline submissions are costly and likely to be of limited value
- Lifecycle management
- Consolidated approach to drafting of dossier
Mandatory Deadlines to make an eCTD FDA submission
Electronic submission of standardized study data for NDA, BLA, ANDA,
and Commercial IND - September 15, 2021
How can Freyr help?
- Guarantee your ROI with an eCTD software that optimizes cost-per-submission
- Integration with inbuilt eCTD validator and PDF manager, submissions tracker and HA query management tool
- eCTD software solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment for more information on the same, consult us
Other Countries
EU, Health Canada, Switzerland, South Africa, Australia, EAEU, Jordan, Thailand, GCC, ASEAN, NMPA
References
