An article focused on regulatory operations argues that submission readiness depends on more than compiling scientific evidence into an eCTD. It stresses that regulators can only evaluate what is delivered as a complete, technically compliant, internally consistent, and navigable application. The piece highlights that publishing and eCTD navigation require specialized operational planning, including validation criteria, metadata management, document lifecycle control, and project tracking across modules, owners, and review cycles. For biotech teams managing parallel NDA and MAA filings, the operational message is direct: readiness should be built in parallel with regulatory strategy, not after the science package is frozen, because late-stage volume spikes can create filing vulnerability.