Regulatory Hub — Overview
Welcome to Regulatory Hub, your enterprise command centre for life sciences regulatory operations. This dashboard provides a real-time snapshot of your global regulatory portfolio spanning applications, submissions, correspondence, commitments, and inspection readiness across all markets. Use the navigation to drill into any domain.
Upcoming MilestonesView plans
| Milestone | Plan | Due Date |
|---|---|---|
| CSR review | Lifecycle Extension Submission | 2025-01-07 |
| Dispatch submission | sMAA Submission Plan 117 | 2025-01-10 |
| Regulatory review | NDS Submission Plan 51 | 2025-01-13 |
| CSR review | sBLA Submission Plan 121 | 2025-01-14 |
| Regulatory review | BLA Submission Plan 45 | 2025-01-15 |
| Quality review | sMAA Submission Plan 50 | 2025-01-15 |
| QC check | sMAA Submission Plan 87 | 2025-01-15 |
| CSR draft | Label Update Submission Plan 1 | 2025-01-15 |
| CSR draft | NDS Submission Plan 46 | 2025-01-16 |
| Regulatory review | MAA Submission Plan 104 | 2025-01-16 |
Overdue CommitmentsView all
| Commitment | Due | Owner | Priority |
|---|---|---|---|
| Provide 36-month accelerated stability data for … | 2024-10-27 | Marcus Webb | medium |
| Complete Phase IV post-marketing observational s… | 2024-12-18 | Carlos Mendez | high |
| Provide confirmatory bioequivalence study for 20… | 2025-05-01 | Tomoko Ikeda | medium |
| Provide confirmatory bioequivalence study for 20… | 2025-02-17 | Lieselotte van der Berg | low |
| Update SmPC section 4.4 with hepatic impairment … | 2024-12-30 | Sarah Chen | high |
| Validate analytical method for dissolution test … | 2025-03-01 | Aisha Okonkwo | low |
Recent ActivityFull log
16
DOWNLOADED — Correspondence COR-384
04
APPROVED — Dossier DOS-271
02
ACKNOWLEDGED — PublishingJob PUB-377
19
DISPATCHED — Dossier DOS-125
17
SUBMITTED — DispatchEvent DIS-347
16
APPROVED — Commitment COM-123
19
DELETED — Variation VAR-315
06
REJECTED — LabelArtifact LAB-392