Welcome to eCTD Submit

Customer-focused regulatory submission services

A Decade of Success: Why eCTD Submit is The Preferred Partner for eCTD Submissions

At eCTD Submit, trust and reliability are the foundational elements of our successful client relationships. We’ve built over a decade of effective collaboration atop smooth and error-free FDA submissions with rapid turnaround times—often 24 to 48 hours—all enabled by our simple, intuitive eCTD Navigator™ and our team’s deep regulatory expertise.

Many of our clients keep working with us even as they transition to new roles or new organizations. For instance, this client of over a decade has continued to utilize eCTD Submit’s publishing solutions while working at four different organizations—and we’ve been proud to achieve successful submissions in each engagement along the way.

Forming a Trusted Partnership

We’re delighted so many of our clientele are first introduced to us by word-of mouth. Peer recommendations are invaluable, especially when so many of our clients deal with the same common challenges and experiences with substandard eCTD publishing:

  • Submission inefficiencies
  • Lack of timeline flexibility
  • Lack of accountability
  • Rigid processes that cannot be changed

Our clients deeply value our ability (and willingness!) to adapt to the unique submission needs of every project. In the case of our client who continued with us across 4 different organizations, it was the quality of our work coupled with the availability of the eCTD Submit team that led the client to use eCTD Submit’s services with every new company they joined.

eCTD Submit’s Unparalleled Reliability and Flexibility

Often, vendors in the eCTD publishing industry impel clients through the same pain points over and over again, whether prolonged submission timelines, confusing and difficult-to-navigate submission platforms, or inaccessible communication with submission teams.

But with eCTD Submit, our team of regulatory experts are able to meet every critical timeline you may bring us. As one client put it, “the eCTD team was able to move heaven and earth to deliver a full BLA submission in just two weeks.”

Read the Case Study

Simplifying the regulatory submission process requires deep domain expertise, and it means remaining consistently flexible and able to problem-solve on the go. eCTD Submit works with your team to proactively address potential submission issues and drive high standards. And with real-time communication at each step of the process, any urgent document adjustments are handled smoothly, mitigating costly delays.

By investing in our customers’ success and integrating with their teams, we’re able to garner an intimate understanding of unique client needs, enabling eCTD Submit to stay ahead of the submission timeline every step of the way.

Enabling Centralized Document Review through an Intuitive eCTD Management System: The eCTD Navigator™

For eCTD regulatory publishing, our eCTD Navigator™ tool enables instantaneous document review in a simple, web-based format that’s easy to use even for first-time users. Enhancing document QC processes, the eCTD Navigator’s built-in eCTD viewer empowers clients to review their documents in the same format the FDA would view them.

Clients report being so highly satisfied with the eCTD Navigator™ that they recommend it (and us) to their industry peers.

Partner with eCTD Submit Today

Looking to experience a flexible, reliable eCTD publishing solution that works for you?

We’ve been performing eCTD submissions since the inception of the eCTD itself.

Contact the eCTD Submit team today to see how we can meet your unique submission needs.

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