sMAA Submission Plan 58

Open Content Assembly

This submission plan coordinates owners, milestone dependencies, and readiness controls for Crizomax. Teams use it to monitor timeline health, resolve blockers, and decide whether content is publish-ready for sequence assembly. Readiness is calculated from deterministic component approval status across linked dossiers, rather than manual estimates. Use the edit and content assembly actions to move directly into corrective work.

Plan ID
PLAN-058
Application
SAHPRA-2022-0058
Target Date
2025-08-02
Status
Blocked
Owner
Priya Sharma
Created
2022-05-02
Readiness Score
15/100
Calculated from 3 approved of 20 linked content components.
Blockers
5 components are missing approval snapshots.
5 components still have unresolved review comments.
Cross-market label harmonisation open
Authority clarification needed on comparator study
Phase III data reconciliation ongoing
Milestone Dependency Strip
QC check
Data cutoff
Authority acknowledgement expected
CSR draft
Module 5 compilation
Dispatch submission
Module 3 update
Publishing start
Protocol finalization
Regulatory review
MilestoneDue DateOwnerDependenciesDependency IndicatorsCompleted
QC check2025-02-18Sarah ChenNoneIndependentYes
Data cutoff2025-03-21Carlos MendezPLAN-058-MS-001DependentNo
Authority acknowledgement expected2025-04-30Lieselotte van der BergNoneIndependentYes
CSR draft2025-05-25Tomoko IkedaNoneIndependentNo
Module 5 compilation2025-06-29Dmitri VolkovNoneIndependentYes
Dispatch submission2025-08-07Sarah ChenPLAN-058-MS-005DependentYes
Module 3 update2025-08-22Priya SharmaPLAN-058-MS-006DependentNo
Publishing start2025-09-22Lieselotte van der BergNoneIndependentNo
Protocol finalization2025-10-16Priya SharmaNoneIndependentYes
Regulatory review2025-11-09Sarah ChenPLAN-058-MS-009DependentYes