At a Glance
When a current client—a Senior Vice President of Regulatory Affairs—transitioned to a new role, eCTD Submit remained his first choice for regulatory submission publishing. This time, the client sought quick FDA submission turnaround and accommodation of corporate data security requirements. eCTD Submit’s flexible approach, fast timelines, high-quality service and user-friendly eCTD Navigatorˢᴹ tool once again proved to be invaluable.
Challenges
In the client’s previous roles, handling submissions with other eCTD vendors had introduced inefficiencies in quality control (QC) processes, lengthy publishing times, and cumbersome tools that hindered real-time communication with the publisher. It was clear that finding an eCTD submission vendor with a high degree of flexibility and technical expertise was essential to meet tight timelines, especially across multiple time zones.
Our Approach
eCTD Submit addressed these challenges through proactive communication, speed, and user-friendly solutions tailored to specific submission needs. The instantaneous review of submission documents enabled by the web-based eCTD Navigatorˢᴹ tool allowed the client to provide direct feedback to the eCTD Submit publishing team. Notified instantly, the publishing team responded immediately, ensuring a seamless collaboration, and the client and eCTD Submit completed the submission without any delays.
Additionally, eCTD Submit’s flexibility in accommodating the client’s unique security requirements enabled the client to use their own hosted solution, which allowed the client to maintain control over their own sensitive documents while ensuring regulatory compliance.
3 Key Points
- Time Zone Advantage
eCTD Submit’s East Coast location provides a practical advantage for EU clients: extended workdays, with completed documents ready the following morning. - Ease of Use and Real-Time Feedback
The eCTD Navigatorˢᴹ’s web-based access and intuitive interface allowed the client to review submissions and provide feedback to the publishing team directly in the tool, avoiding the hassle of offline exchanges. - Reliable Speed and Flexibility
Exceptional turnaround—delivering hundreds of pages within 2 business days—meant submissions stayed on schedule, even with last-minute changes.
Solutions
With eCTD Submit’s cloud-based eCTD Navigatorˢᴹ tool and responsive submission publishing experts, this client streamlined their regulatory submission processes without compromising quality. The eCTD Navigatorˢᴹ ensures data security while allowing for real-time document review and improved collaboration. And for data security, eCTD Submit isn’t limited to any one solution; the agreed upon security arrangements ensured the client’s sensitive data stayed protected and remained in their control. The client’s confidence in eCTD Submit’s expertise and responsiveness transformed the partnership into a seamless extension of their team.
Who We Are
At eCTD Submit, we’ve managed thousands of successful regulatory applications. When you work with eCTD Submit, you experience direct access to trusted experts in eCTD submission publishing and compliance. 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. With our intuitive web-based eCTD Navigatorˢᴹ, you’ll achieve diligent and complete QC review of all your relevant documents while remaining comfortably within budget
Our clients continue to return to eCTD Submit, even as they move between organizations, a testament to the high levels of trust and satisfaction with our services.
On ease of use and real-time feedback:
“You can just literally view things at the drop of a hat… Feedback comments back through the software; I’ve never seen that in any other software.”
