For years, we’ve been keeping our clients’ submission documents secure and easy to access. Because, as any sponsor knows, maintaining FDA submission records is not just a responsibility ‒ it’s a regulatory publishing requirement.
How do we achieve this? Well, first we use a document management platform that doesn’t lock you into a single system. This gives you full control with immediate access to any module, section, or document in your eCTD submission.
And locating documents couldn’t be easier with our NavigatorTM tool. It’s an intuitive web-based interface that mirrors the FDA’s lifecycle view. So, your view of your regulatory submission is the same as that of the FDA reviewer.
The dangers of taking a wrong turn
Failing to meet the FDA’s regulatory publishing requirements can lead to missed deadlines, which can increase costs – and greater costs mean unhappy management.
Often the delays have nothing to do with the sponsor. Many find themselves under pressure from the FDA due to their vendor’s choices. For example, a vendor may mistakenly:
- Use an outdated regulatory submission system that causes compliance risks – poor document management is major FDA compliance issue.
- Rely on an archaic, hard-to-navigate submission platform – an FTP site, for example. If the information requested by the FDA is not at your fingertips, you may quickly become the subject of a formal inspection finding.
- Be unclear as to where or how your submission is stored – this runs the risk of the FDA ruling your program as noncompliant.
You know where you are with eCTD Submit
At eCTD Submit we help smooth the path from early development right through to regulatory approval and beyond. After all, a well mapped out eCTD submission isn’t just helpful – it’s essential.
To find out more get in touch today.
Because with eCTD Submit you can improve accuracy, reduce costs, avoid delays and reach your destination sooner.