Regulatory reviewers can only evaluate a marketing authorization application when it is translated into a complete, compliant, and internally consistent dossier. A new piece on submission readiness argues that “regulatory operations” is often treated as a late-stage task, even though high-quality eCTD assembly depends on operational planning running in parallel with regulatory strategy. The article emphasizes that publishing is not just a matter of using eCTD software. Instead, it requires technical mastery of eCTD architecture, validation requirements, metadata, document lifecycle controls, and the navigational structure reviewers rely on to move efficiently through large applications. With late-stage document volume surges, teams need sufficient experienced publishing capacity and rapid escalation processes. For parallel NDA and MAA submissions, the operational burden increases because regional requirements and application structures may differ, potentially involving different eCTD standards. The piece also highlights infrastructure needs around document management, version integrity, and project-tracking systems to maintain visibility across modules, owners, and review cycles.