At a Glance
Our client, a small biotech startup, needed eCTD submission outsourcing to handle their regulatory submission publishing. The CMO was tasked with identifying a regulatory submission publishing vendor capable of delivering high-quality submissions within tight deadlines to maintain shareholder trust and avoid impact to their public reputation.
Challenges
The client’s small size meant minimal internal resources for regulatory submission publishing, but meeting timelines was critical. The CMO had seen how large vendors often lacked responsiveness—but this was an essential element for a small team that relied upon quick and responsive support. What the client needed was flexibility and reliability. Furthermore, they needed a partner who they could trust without risking submission failures.
Our Approach
From the outset, eCTD Submit was confident they would deliver. The client was granted unfettered access to key team members, including direct contact with the project manager. During document quality control (QC) review, the eCTD Navigatorˢᴹ tool coupled with regular quality reviews ensured compliance and accuracy of the submissions at every step. And with real-time updates and proactive issue resolution, this trust and transparency made eCTD Submit function as a true extension of the client’s team.
3 Key Points
- Reliable and responsive: Communication in real time created a strong working relationship.
- Cost-effective and high-quality: Premium submission quality without premium pricing.
- Integrated team: eCTD Submit acted as a true partner, unafraid to advise or challenge client strategy.
Solutions
eCTD Submit’s tailored submission solutions provided robust security and regulatory compliance, ensuring strict adherence to FDA requirements while delivering peace of mind to the client’s leadership. To bridge gaps in the client’s internal capabilities, eCTD Submit implemented a scalable and flexible support model, leveraging the eCTD Navigatorˢᴹ for comprehensive submission reviews to prevent errors. For smaller organizations like this client, outsourcing eCTD publishing to eCTD Submit means a seamless submission process that prioritizes accuracy, speed, and quality.
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
On our high-quality standards and process:
“The quality review process is ongoing on a continuous basis… like a well-oiled machine. They ensure quality is held to a rigorous standard.”
