How to Manage a Cross-Functional eCTD Submission Team

For small pharma or biotech companies looking to submit their first big application, whether it’s an IND, NDA or BLA, it’s important to help your key players, who likely have ongoing responsibilities outside of this deliverable, understand that they all play a vital part in the success of the submission!

This may be the first time some (or all) of your team members are participating in a milestone eCTD submission, but even if you’ve got seasoned professionals in critical roles, coordinating a cross-functional eCTD submission team across multiple functions – which may include Regulatory Affairs, Medical Writing, Document Formatting, Submission Publishing, multiple vendors, and beyond – depends on seamless communication and a well-structured plan.

But there’s no need to feel overwhelmed! Use our guide below to learn how to manage an eCTD submission effectively across functions.

1. Set the Stage with a Cross-Functional eCTD Submission Team Overview

• Define Submission Type: Clearly communicate whether it’s an IND, NDA, BLA, or other submission type so all teams understand the regulatory expectations.

• Establish Milestones: Set clear timelines for key deliverables, including drafting, reviewing, formatting, and submission publishing.

• Assign Functional Leads: Identify a lead from each function to act as the point of contact for updates and issue resolution.

2. Collaborate on Document Inventory

• Module Breakdown: Break down required documents by CTD module (e.g., Modules 1-5). Ensure all functions understand their responsibilities for each module.

• Ownership and Roles: Assign specific tasks such as authoring (Medical Writing), reviewing (Regulatory Affairs), and formatting (Document Formatting).

• Document Status Tracking: Use shared tools to track progress, such as "Drafting," "In Review," or "Finalized."

3. Align Regulatory Commitments

• Incorporate Feedback: Regulatory Affairs should share prior agency feedback with all relevant functions to guide content development.

• Monitor Deadlines: Ensure everyone knows agency-imposed deadlines and internal milestones to avoid last-minute scrambles.

4. Build a Cross-Functional Content Development Timeline

• Interdependent Milestones: Highlight tasks that rely on input from multiple teams, such as clinical data summaries requiring Medical Writing and Biostatistics collaboration.

• Review Cycles: Schedule internal reviews with sufficient time for feedback and revisions.

• Buffer Time: Account for potential delays, especially in cross-functional tasks.

5. Standardize Technical Specifications

• Word Document Formatting: Document Formatting should ensure all Word documents are consistently styled, with appropriate headings, tables, and font usage.

• PDF Compliance: Submission Publishing should ensure final PDFs meet FDA’s specifications, including validation checks.

• Bookmarks and Hyperlinks: Submission Publishing is responsible for verifying that bookmarks and hyperlinks are accurate and functional.

• Consistent Naming Conventions: Use agreed-upon file naming standards to streamline file management.

6. Implement a Submission Readiness Checklist

• Cross-Functional QC: Include checks for hyperlinks (Submission Publishing), document accuracy (Medical Writing), and compliance with agency guidelines (Regulatory Affairs).

• Review Navigation: Ensure Submission Publishing has optimized bookmarks and navigation for usability.

• Final Approvals: Confirm all functions sign off before submission.

7. Foster Team Communication

• Regular Updates: Schedule weekly cross-functional meetings to review progress and address challenges.

• Shared Dashboards: Use a centralized tracking system to provide real-time status updates.

• Clear Escalation Paths: Define how and when to escalate issues to leadership.

8. Plan for Risk Management

• Identify Potential Issues: Each team should anticipate challenges related to their function and propose solutions.

• Develop Contingency Plans: For example, have backup resources available for critical tasks like final QC reviews.

• Monitor Workload: Ensure no single function is overwhelmed by submission deadlines.

9. Coordinate Submission Handoff and Archival

• Final File Transfers: Ensure Submission Publishing receives all finalized documents in a timely manner.

• Archival Responsibilities: Assign archiving tasks to ensure all content is stored securely and accessibly post-submission.

• Plan Ahead for Required or Potential Next Steps: It’s best to be proactive instead of reactive when it comes to preparing for next submissions. Expecting feedback? Make sure resources are on standby to address any anticipated questions. Are there required submissions ahead (e.g., annual reports or DSURs, required reporting, etc.)? Get any submissions you can on the calendar and make sure the project leads are aware of what’s coming.

Why Cross-Functional Coordination Matters

An eCTD submission is only as strong as the collaboration behind it. Each function contributes unique expertise, but without coordination, even small missteps can lead to delays or compliance issues. By following these steps, you can foster a cohesive, well-organized team effort that ensures high-quality submissions on time and within regulatory expectations.

Ready to elevate your submission strategy? The Sugar Water Operations Team can help you bring your team together with a communication and execution plan designed for your resources and needs, whether that’s Project Management support or complete submission management and publishing of your eCTD. Contact us to discuss how we can help!