Regulatory Hub

Visual representations of the five core regulatory operating workflows. Each swimlane shows the actor-step sequence from initiation to outcome. These workflows are embedded in the platform's task orchestration layer and can be configured per market and procedure type. No create buttons are shown here — workflows are initiated from the relevant functional pages.

New Marketing AuthorisationWF-01

Full lifecycle from development to first-in-market approval

Reg Affairs	Step 1 Dossier strategy →	Step 2 Target label development →	Step 3 Pre-submission meeting →	Step 4 Review CTD modules
Content Ops	Step 1 Module compilation →	Step 2 Component versioning →	Step 3 Cross-module consistency →	Step 4 Content freeze
Publishing	Step 1 eCTD sequence build →	Step 2 Validation run →	Step 3 QC review →	Step 4 Package assembly
Dispatch	Step 1 Gateway submission →	Step 2 ACK receipt →	Step 3 Clock start →	Step 4 Question tracking
Authority	Step 1 Validation check →	Step 2 Scientific review →	Step 3 Day-120 questions →	Step 4 Opinion / Approval

Variation (Type IB)WF-02

Post-approval change management for Type IB variations

Reg Affairs	Step 1 Change notification →	Step 2 Variation classification →	Step 3 Impact assessment →	Step 4 Filing strategy
CMC / Quality	Step 1 Technical justification →	Step 2 Stability data →	Step 3 Comparative studies →	Step 4 Batch analysis
Publishing	Step 1 Module 3 update →	Step 2 Validation →	Step 3 Sequence assembly
Dispatch	Step 1 Submission to authority →	Step 2 Acknowledgement →	Step 3 Approval tracking

Authority Question ResponseWF-03

Response to Day-120 / Day-180 List of Questions

Authority	Step 1 Question issued →	Step 2 Clock stop
Reg Affairs	Step 1 Question triage →	Step 2 Response strategy →	Step 3 Expert coordination →	Step 4 Response draft
Medical / Clinical	Step 1 Clinical data analysis →	Step 2 Benefit-risk update
Publishing	Step 1 Response package assembly →	Step 2 Validation →	Step 3 Submission
Authority	Step 1 Clock restart →	Step 2 Final assessment →	Step 3 Outcome

Label UpdateWF-04

SmPC / PIL revision following new clinical or safety data

Pharmacovigilance	Step 1 Signal detection →	Step 2 Benefit-risk assessment →	Step 3 SmPC update trigger
Labeling	Step 1 Core label update →	Step 2 Market adaptation →	Step 3 Statements library update →	Step 4 Review & approval
Reg Affairs	Step 1 Variation filing →	Step 2 Cover letter →	Step 3 Multi-market coordination
Publishing	Step 1 Label sequence →	Step 2 Artwork update →	Step 3 Submission package

Regulatory Inspection PreparationWF-05

GMP / GCP pre-inspection readiness assessment and pack assembly

Quality	Step 1 Readiness assessment →	Step 2 Gap analysis →	Step 3 CAPA closure →	Step 4 Mock inspection
Reg Affairs	Step 1 Document listing →	Step 2 Dossier alignment check →	Step 3 Response strategy prep
IT / Validation	Step 1 System validation review →	Step 2 Audit trail export →	Step 3 Validation evidence pack
Inspector	Step 1 Inspection pack submission →	Step 2 Opening meeting →	Step 3 Document requests →	Step 4 Closing meeting

End-to-End Workflows