Q: If a company is submitting its first eCTD, is it necessary that they first get some dummy file validated or checked by the USFDA and then submit the real dossier?
A: No. That said, if you are creating the submission by hand, then it would be a good idea to submit some dummy files first.
A: We certainly feel that we have the best offering for publishing, validation, and review. Our VALIDATE and REVIEW products are the very tools used by the FDA, and so the need for quality is quite clear. PUBLISH has been built to be simple, intuitive, and easy to use, and is built on our solid foundation of VALIDATE and REVIEW
A: The current ICH eCTD specification, V3.2.2, can be found on the ICH website.