Submission Plans

Submission plans define the milestone-driven roadmap for each regulatory submission. Each plan includes a target submission date, readiness score, milestone timeline, and blocker list. Plans with readiness below 75 are flagged for escalation.

IDPlan NameApplicationTarget DateReadinessMilestonesBlockersOwnerStatus
PLAN-001Type II Variation Submission Plan 1FDA-2024-00012025-07-25
66%
53Lieselotte van der BergApproved
PLAN-002Type IA Variation Submission Plan 2EMA-2023-00022025-08-02
89%
70Marcus WebbSubmitted
PLAN-003Type IB Variation Submission Plan 3PMDA-2022-00032025-02-15
81%
90Marcus WebbBlocked
PLAN-004MAA Submission Plan 4NMPA-2021-00042025-11-04
90%
50Nadia PetrovaFailed
PLAN-005Type IB Variation Submission Plan 5ANVISA-2020-00052025-05-30
94%
40Sarah ChenOverdue
PLAN-006sNDA Submission Plan 6HC-2024-00062025-09-06
82%
40Sarah ChenSubmitted
PLAN-007Label Update Submission Plan 7TGA-2023-00072025-11-19
81%
40Marcus WebbOverdue
PLAN-008sMAA Submission Plan 8MHRA-2022-00082025-05-09
76%
90Aisha OkonkwoActive
PLAN-009MAA Submission Plan 9SwissMedic-2021-00092025-12-08
54%
73James O'BrienActive
PLAN-010NDS Submission Plan 10MFDS-2020-00102025-07-01
50%
92Sarah ChenOverdue
PLAN-011Type IB Variation Submission Plan 11TFDA-2024-00112025-06-05
48%
81Lieselotte van der BergOverdue
PLAN-012sNDA Submission Plan 12HSA-2023-00122025-02-13
75%
90Sarah ChenFailed
PLAN-013NDA Submission Plan 13CDSCO-2022-00132025-12-21
61%
53Priya SharmaApproved
PLAN-014MAA Submission Plan 14COFEPRIS-2021-00142025-05-25
73%
72Dmitri VolkovPending
PLAN-015Lifecycle Extension Submission Plan 15ANMAT-2020-00152025-08-06
90%
50Lieselotte van der BergBlocked
PLAN-016sBLA Submission Plan 16TITCK-2024-00162025-10-21
97%
40Carlos MendezApproved
PLAN-017sMAA Submission Plan 17SFDA-2023-00172025-02-28
66%
43Sarah ChenPending
PLAN-018Lifecycle Extension Submission Plan 18SAHPRA-2022-00182025-09-27
60%
51Dmitri VolkovSubmitted
PLAN-019sBLA Submission Plan 19Roszdravnadzor-2021-00192025-12-11
81%
60Nadia PetrovaIn Progress
PLAN-020NDA Submission Plan 20MOH-IL-2020-00202025-04-04
92%
50James O'BrienSubmitted
PLAN-021sBLA Submission Plan 21FDA-2024-00212025-11-02
77%
80Aisha OkonkwoIn Progress
PLAN-022MAA Submission Plan 22EMA-2023-00222025-09-09
68%
73Nadia PetrovaCompleted
PLAN-023Lifecycle Extension Submission Plan 23PMDA-2022-00232025-04-11
92%
100Priya SharmaPending
PLAN-024Type IA Variation Submission Plan 24NMPA-2021-00242025-09-15
80%
100Dmitri VolkovSubmitted
PLAN-025MAA Submission Plan 25ANVISA-2020-00252025-05-18
63%
82Priya SharmaActive
PLAN-026sNDA Submission Plan 26HC-2024-00262025-04-22
86%
50Priya SharmaActive
PLAN-027NDA Submission Plan 27TGA-2023-00272025-08-19
51%
52Priya SharmaFailed
PLAN-028sMAA Submission Plan 28MHRA-2022-00282025-07-03
97%
80Sarah ChenApproved
PLAN-029NDS Submission Plan 29SwissMedic-2021-00292025-06-15
65%
61Sarah ChenIn Progress
PLAN-030sMAA Submission Plan 30MFDS-2020-00302025-02-10
52%
102Sarah ChenPending
PLAN-031sBLA Submission Plan 31TFDA-2024-00312025-11-07
78%
70Marcus WebbSubmitted
PLAN-032sBLA Submission Plan 32HSA-2023-00322025-10-02
88%
80James O'BrienCompleted
PLAN-033Type IB Variation Submission Plan 33CDSCO-2022-00332025-02-23
72%
83Marcus WebbSubmitted
PLAN-034Lifecycle Extension Submission Plan 34COFEPRIS-2021-00342025-07-07
90%
90Carlos MendezOverdue
PLAN-035MAA Submission Plan 35ANMAT-2020-00352025-06-19
98%
50Nadia PetrovaSubmitted
PLAN-036Type IB Variation Submission Plan 36TITCK-2024-00362025-04-10
43%
61Dmitri VolkovCompleted
PLAN-037Lifecycle Extension Submission Plan 37SFDA-2023-00372025-10-03
50%
82Aisha OkonkwoActive
PLAN-038sBLA Submission Plan 38SAHPRA-2022-00382025-04-15
67%
103Nadia PetrovaBlocked
PLAN-039Type IB Variation Submission Plan 39Roszdravnadzor-2021-00392025-03-04
80%
60Marcus WebbCompleted
PLAN-040BLA Submission Plan 40MOH-IL-2020-00402025-03-20
47%
103Lieselotte van der BergApproved
PLAN-041sNDA Submission Plan 41FDA-2024-00412025-10-04
62%
61Lieselotte van der BergCompleted
PLAN-042NDS Submission Plan 42EMA-2023-00422025-04-27
83%
100Priya SharmaDraft
PLAN-043Label Update Submission Plan 43PMDA-2022-00432025-08-12
94%
80Carlos MendezIn Progress
PLAN-044sMAA Submission Plan 44NMPA-2021-00442025-09-23
53%
101Sarah ChenIn Progress
PLAN-045BLA Submission Plan 45ANVISA-2020-00452025-04-27
66%
52Marcus WebbApproved
PLAN-046NDS Submission Plan 46HC-2024-00462025-09-23
71%
52Nadia PetrovaApproved
PLAN-047NDA Submission Plan 47TGA-2023-00472025-05-29
77%
40James O'BrienCompleted
PLAN-048Type IB Variation Submission Plan 48MHRA-2022-00482025-02-11
47%
72Lieselotte van der BergDraft
PLAN-049Type II Variation Submission Plan 49SwissMedic-2021-00492025-10-03
47%
73Sarah ChenFailed
PLAN-050sMAA Submission Plan 50MFDS-2020-00502025-08-13
49%
82James O'BrienApproved
PLAN-051NDS Submission Plan 51TFDA-2024-00512025-09-30
72%
93Lieselotte van der BergBlocked
PLAN-052Type IA Variation Submission Plan 52HSA-2023-00522025-03-09
45%
91Lieselotte van der BergIn Progress
PLAN-053Type II Variation Submission Plan 53CDSCO-2022-00532025-11-09
61%
41James O'BrienIn Progress
PLAN-054sNDA Submission Plan 54COFEPRIS-2021-00542025-10-04
97%
50Aisha OkonkwoBlocked
PLAN-055Label Update Submission Plan 55ANMAT-2020-00552025-06-17
64%
53Tomoko IkedaCompleted
PLAN-056Label Update Submission Plan 56TITCK-2024-00562025-09-09
70%
41Aisha OkonkwoApproved
PLAN-057Lifecycle Extension Submission Plan 57SFDA-2023-00572025-07-30
98%
70Dmitri VolkovActive
PLAN-058sMAA Submission Plan 58SAHPRA-2022-00582025-08-02
47%
103Priya SharmaBlocked
PLAN-059BLA Submission Plan 59Roszdravnadzor-2021-00592025-04-23
79%
40James O'BrienSubmitted
PLAN-060Lifecycle Extension Submission Plan 60MOH-IL-2020-00602025-06-08
78%
80Priya SharmaOverdue