At A Glance – A Decade of Reliable eCTD Management System
With a collaborative working relationship spanning over 10 years, this client has utilized eCTD Submit’s services across four different organizations, delivering consistent, error-free FDA submissions at each. The client cites eCTD Submit’s unwavering flexibility and thorough QC as reinforcing the trust that’s only found in a publisher vendor of eCTD Submit’s caliber. Finally, eCTD Submit’s efficient review process, enhanced communication, and effortless user experience have made it a mainstay for the client.
Challenges
Prior eCTD publishing vendors had struggled to meet this client’s submission needs due to incompatible processes. Impact to the client included high cost, overage fees, and constant delays. As a result of these negative experiences, the client knew exactly what they were looking for: a flexible, and responsive partner, one that enabled easy document access/viewability and efficient QC processes.
On the cusp of our initial engagement the client faced tight timelines, thousands of pages, and a long list of last-minute changes to be made before their official submission.
Our Approach
Working closely with the client, eCTD Submit created a tailored submission plan that balanced flexibility with rigorous quality standards. Our eCTD Navigatorˢᴹ delivered seamless, centralized document review capabilities which enabled the client to review their submissions exactly as the FDA would see them and work ahead of potential issues to drive high-quality final submissions and avoid costly delays. eCTD Submit’s ability to function as an extension of the client’s team improved the strategic insight necessary to stay ahead of deadlines with confidence.
3 Key Points
- Flexible and Fast Turnaround Times – eCTD Submit consistently meets tight deadlines and adapts to last-minute changes.
- High-Quality, Reliable Outputs – commitment to quality, rigorous internal checks, and reduced review burden
- Intuitive eCTD Navigatorˢᴹ Tool – ease of use, transparency, agency-perspective view
Solutions
eCTD Submit’s quality processes and consistent publishing timeframes secured timely submissions for this client despite the last-minute pressures, avoiding overage fees and keeping their project on schedule. eCTD Submit’s deep submission expertise and collaborative focus supported on-schedule submissions even with minimal lead time. The intuitive workflow of the eCTD Navigatorˢᴹ tool improved QC processes and empowered the client team to catch and address document errors far ahead of deadline.
The collaboration between eCTD Submit and the client grew into a trusted partnership, and today, the client knows they can always count on eCTD Submit to deliver their submissions on time.
Who We Are and How Reliable Is Our eCTD Management System?
Many of our clients continue to work with eCTD Submit, even as they move between organizations, a testament to the high level of trust and satisfaction they find in our services.
We’ve managed thousands of successful applications. When you work with eCTD Submit, you experience direct access to trusted experts in eCTD submission publishing. With user-friendly templates, compliant submissions are simple for even first-time users. And you can easily transfer your existing applications into our eCTD Navigatorˢᴹ system.
On the eCTD Navigatorˢᴹ tool’s impact
“When I got access to their eCTD Navigatorˢᴹ, it was kind of like, this is amazing…It gives you exactly what you need and provides you an interface where you can actually access the documents in a meaningful and useful way.”
