CRED Getting the CMC Dossier Right 2024

28/08/2024

How Do Finished Product Specifications Evolve?

The Organisation for Professionals in Regulatory Affairs

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How do Finished Product Specifications Evolve?

Clinical Phase •

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Phase 1 (FIH)

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Phase 2

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Phase 3

Initial Filing

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• Initial Commercial / Agency Approval

Post-approval Change

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The Organisation for Professionals in Regulatory Affairs

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