Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).
What does it take to have a successful eCTD submission? Here are four tips from our Associate Director of Regulatory Operations, Heather Sinsel.
1. Connect the project team with a GLOBAL Project and Submission Manager.
Our Regulatory Operations Team knows there are a lot of moving parts to review, validate, and approve for your eCTD submission. Although GLOBAL uses a matrixed team approach, there’s a single point of contact with your team throughout the lifecycle of each project.
GLOBAL’s Project and Submission Managers (P&SM) hold the pieces together throughout the project, beginning with the details of what goes into your submission! The P&SM will work seamlessly with your internal teams, subject matter experts, and publishers at GLOBAL to ensure that timelines are met.
2. Choose a vendor (psst...GLOBAL!) with technical industry knowledge to develop your eCTD submission strategy.
eCTD guidance changes often and our team takes pride in keeping up to date on all of it! Your team can rely on GLOBAL’s knowledge of eCTD guidance and regulations. GLOBAL’s publishing experts research many sources, including the FDA and ICH websites, to remain current on the guidelines.
We communicate openly and clearly with you throughout the submission process. The eCTD publishers use their exceptional attention to detail to ensure compliance at every step of the publishing and submission process.
To learn more about these resources, check out the following links:
3. Copyediting is CRITICAL.
GLOBAL’s copyediting team is available throughout the submission process.
Submission-ready documents take less time to publish. Without copyediting services, publishers could encounter errors during compilation and publishing; this can add substantial time to your submission. GLOBAL’s copyeditors make sure that your documents are submission ready. Here are some common errors that can be resolved during the copyediting process:
External links present in your documents
Broken links and bookmarks
4. Choose great technology that focuses on industry standards and compliance!
GLOBAL’s team of publishing experts uses Certara’s industry-leading eCTD submission technology to support your team’s plan. We chose this software to ensure timely and exceptional output for our clients.
Certara’s GlobalSubmit (GlobalSubmit) software integrates ever-changing eCTD regulations in real time. Their variety of tools (PUBLISH, VALIDATE, WebReview, and REVIEW) eliminate unnecessary steps with a simplified eCTD submission process. This streamlined process supports your regulatory team by mitigating risks as they race to meet deadlines and deliver treatments to patients.
Want to learn more about working with our Regulatory Operations Team? Connect with our Associate Director of Regulatory Operations, Heather Sinsel, PMP, by emailing firstname.lastname@example.org to schedule a quick initial assessment.