Integrated Approach to CTD Module 3 Submission for Drug-Device Combination Products

Description: Preparing Module 3 of the Common Technical Document (CTD) for drug-device combination products presents unique challenges. Regulatory expectations require the integration of both drug and device constituent information in a way that clearly demonstrates product quality, safety, and performance—consistently structured and backed by traceable sources of evidence. Yet many organizations struggle with fragmented documentation, inconsistent narratives, and siloed development efforts.

This session introduces a structured, integrated approach to preparing Module 3 for combination products. It emphasizes the alignment of drug substance and device constituent information into a coherent, traceable submission package. We will walk through practical examples of using digital tools to configure modular templates, auto-populate live content from authoritative sources, and establish traceability across foundational documents such as Quality by Design (QbD) documentation, the Design History File (DHF), and the Risk Management File (RMF) to support lifecycle change management.

We will also discuss how this approach reduces reliance on manual reference checks, minimizes errors, improves efficiency in submission preparation and revision cycles, and enhances the clarity and effectiveness of regulatory storytelling. Attendees will gain actionable strategies and insights into leading practices and digital tools that streamline submission documentation while maintaining consistency, enabling timely updates, and reinforcing compliance throughout the product lifecycle.
This session is ideal for combination product teams—including CMC, device, and regulatory functions—preparing global submissions.