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Case Studies

Case Studies

CASE STUDY 1

Integrate Japan Into Global Clinical Development

JAPAN REGULATORY DEVELOPMENT STRATEGY AND PMDA CONSULTATION FOR US-BASED ONCOLOGY COMPANY

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CASE STUDY 2

Japan Entry & NDA

JAPAN ENTRY SET-UP, NDA SUBMISSION AND NEGOTIATION WITH PMDA UNTIL APPROVAL

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CASE STUDY 3

Orphan Designation

ORPHAN DESIGNATION

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CASE STUDY 4

Regulatory Affairs

MAKING SENSE OF CONFLICTING INFORMATION ON REGULATORY AND DRUG DEVELOPMENT STRATEGY

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