It’s time to get your eCTD submission back in shape
Every year the FDA rejects around 2000 eCTD applications. While this represents a tiny percentage of all submissions it can be alarming if yours is one of those rebuffed.
Duplicate sequences and high validation errors comprise the majority of reasons for rejection. Mistakes in single file submissions and missing backbone files will cause DTD errors. While eCTD submission errors are frequently more annoying than they are serious, each can have significant repercussions. A rejection can pause or even halt your development program and, as you know, any delay can make stakeholders nervous.
The team that builds robust eCTD applications
Ensuring a successful eCTD application begins long before the submission date. So, at eCTD Submit we collaborate closely with you. Right from the moment you select us to be part of your team.
We minimize the common challenges many sponsors face: with the eCTD NavigatorTM you’re not locked into a single system. There’s no additional software, no downloads, no apps. You maintain full ownership of every document; after all it’s your eCTD application! It means you can access submission sequences, ESG receipts and all other vital documents at any time on any device, day or night.
Making sure your eCTD submission is fit for purpose
Our eCTD NavigatorTM structure mirrors the FDA’s viewing software. So, your submission view always matches that of the regulator. It makes reviewing documents straightforward and provides unsurpassed standards of accuracy and quality control.
If you’d like us on your side, why not get in touch? As part of your team, we can ensure your next application is absolutely fit for purpose.