Our clients often recall prior attempts to complete eCTD submission publishing in-house, and how complex, strenuous and chaotic that process can be. That’s why many organizations choose to outsource their eCTD publishing needs. At eCTD Submit, we specialize in delivering seamless submissions backed by expert regulatory knowledge, cost-efficient solutions, and rapid turnaround times – some as fast as 24 hours.
With eCTD Submit, you’re partnered with a responsive, dependable team of regulatory experts who are able to quickly grasp your unique submission needs, achieve your turnaround requirements, and adapt to your budget.
Experience Makes the Difference: eCTD Submit is Setting the Bar for eCTD Publishing Services
As a team of experienced eCTD submission professionals, we’ve garnered thousands of successfully submitted applications.
We delegate specifically assigned team members to your submission projects, so you receive diligent one-on-one guidance through every stage of your eCTD submissions, whether it’s to FDA or another national agency. And unlike other eCTD vendors in the industry, we guarantee flexibility with file storage platforms for document storage and exchange. We’re happy to use any secure data management solution, whether that’s SharePoint, Box, Dropbox, Egnyte, etc.—to help ensure your sensitive data stays in your hands.
Simplifying the eCTD Submission Process with eCTD Navigator
Based on the modular eCTD structure, our innovative and intuitive web-based eCTD Navigator™ tool refines and streamlines the document review process. The eCTD Navigator™ enables an instantaneous and comprehensive view of all your submission documents. Here’s a closer look at our process:
- Document Retrieval – We begin by downloading your submission documents from your preferred data management platform, whether it’s SharePoint, Box, Dropbox, or Egnyte.
- Formatting and Publishing – Next, we format your documents to meet agency-specific requirements and eCTD-compliant structures, ensuring every detail aligns with regulatory standards.
- Final Review and QC – Once formatted, we upload the published documents to our eCTD Navigator™ tool, where you can easily review the submission structure, bookmarks, and hyperlinks in a user-friendly web interface.
This seamless process ensures your documents are maintained in a secure environment, are error-free, thoroughly reviewed, and ready for submission with minimal effort on your part.
Achieving Two-Day Turnarounds with Superior eCTD Submission Services
We excel in managing rapid FDA submission turnaround times while ensuring high quality submissions. Just ask our clients.
With our team’s deep experience in FDA submission publishing, your organization can proceed to final submission without the delays that can often occur with larger eCTD service providers who may fail to meet swift turnaround times for urgent submissions like FDA RFIs and IND safety reports.
We begin by establishing a comprehensive understanding of your unique submission requirements in order to deploy a tailored solution. Our streamlined process allows for tremendous flexibility to adapt to your organizational needs, and our eCTD Navigator™ tool ensures high quality submissions.
It’s this consistent experience, smooth turnaround, and worry-free QC that has yielded the long-term working relationships we see with our clients, even as they move between organizations—a testament to high-level trust and satisfaction with our services.
Partner with eCTD Submit
Looking to achieve faster FDA submission turnarounds at your organization? Contact one of our eCTD submission experts today to learn how our services can best fit your unique needs.
