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Create your account and pick the submission role that matches what you do. Your role decides which documents you can author, review, approve, publish or submit across every dossier.

Submission Roles (RACI)
Regulatory Lead
Author · Review · Approve · Submit · Modules: M1, M2
Submission Manager
Review · Modules: M1
CMC Author
Author · Review · Modules: M3, M2_3
Clinical Author
Author · Review · Modules: M5, M2_5, M2_7
Nonclinical Author
Author · Review · Modules: M4, M2_4, M2_6
Medical Writer
Author · Review · Modules: M2, M2_3, M2_4, M2_5
Functional Reviewer
Review · Approve · Modules: —
Publisher / eCTD
Publish · Modules: PUB
Regulatory Operations
Submit · Modules: M1
QA Administrator
Review · Approve · Modules: —

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💊 eCTD submission requirements
🔬 ICH Q10 pharmaceutical quality system
🧪 FDA CMC requirements for biologics
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