Aquila University The eCTD Publishing Process

This video explores the intricate and often underestimated eCTD (Electronic Common Technical Document) publishing process, which is critical for regulatory submissions like NDAs to agencies such as the FDA. The speaker highlights the common misconception among sponsors regarding the time and resources required to convert years of clinical data into a compliant and reviewable eCTD, emphasizing that inadequate planning significantly increases project risk. The discussion details the essential components for eCTD creation, including specialized publishing systems, advanced PDF tools, eCTD validators, and a dedicated team of experienced regulatory operations publishers. The process is broken down into four major activities: lifecycle planning, document remediation, quality control, and project management, with remediation consuming the vast majority of the effort.

Key Takeaways:

• Underestimated Complexity: eCTD publishing is a highly complex, resource-intensive process, with sponsors frequently underestimating the 2,000 man-hours and minimum four months required for a typical 505 B1 NDA (100,000+ pages, 300+ documents).
• Critical Resource Requirements: Successful eCTD publishing necessitates a robust technology stack (publishing system, advanced PDF tools, dual eCTD validators) and a skilled team comprising experienced manager-level and associate-level regulatory publishers.
• Remediation is King: Document remediation, involving cleaning, formatting, bookmarking, and intricate linking of individual PDFs, accounts for approximately 70% of the total project time, underscoring its manual and meticulous nature.
• QC is Non-Negotiable: Cutting corners on the 15% allocated for quality control introduces substantial risk of non-compliance, incorrect versions, broken links, or inconsistent content, which can severely impact reviewer satisfaction and approval chances.
• Operational Challenges: Beyond document processing, significant challenges include managing large file transfers (often 10-20+ GB per submission, requiring multiple transfers) and ensuring seamless integration of new submissions with previous ones.
• Strategic Compliance: Proper eCTD planning and execution are not just technical tasks but strategic imperatives that directly influence regulatory approval timelines and outcomes by ensuring a clear, consistent, and easily reviewable application for regulatory bodies.