💊 Pharma & Life Sciences · Flowchart
Regulatory Submission Workflow
How a pharmaceutical company prepares and files a marketing application (dossier) with regulators and handles their queries.
Drawing diagram…
What this diagram shows
- Dossier is built in the CTD structure from many departments
- Quality checks and publishing before submission
- Regulator queries are answered in formal response cycles
Prompt used
Regulatory submission flowchart: regulatory affairs plans the submission, departments author documents (quality/CMC, non-clinical, clinical) in the CTD format, documents go through review and approval in the document management system, the team compiles and validates the eCTD, publishes it and submits it to the regulator's gateway. The regulator validates and reviews; queries (deficiency letters) are answered in response cycles until approval or rejection, then labelling is finalised.
Mermaid code
flowchart TD
A[Plan submission and timelines] --> B[Author CTD modules: quality, non-clinical, clinical]
B --> C[Review and approve in document system]
C --> D[Compile eCTD]
D --> E{Technical validation passes?}
E -->|No| D
E -->|Yes| F[Submit via regulator gateway]
F --> G[Regulator validation and review]
G --> H{Queries?}
H -->|Yes| I[Prepare response] --> G
H -->|No| J{Decision}
J -->|Approved| K[Finalise labelling and launch]
J -->|Rejected| L[Assess resubmission]Related templates
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