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LyonaPharm Consulting
Drug Development Consultancy
Regulatory Affairs
1. EMA/FDA scientific advice & MAA/BLA submissions
2. Response to authorities via scientific justification
3. Medical writing & biostatistics
Clinical Affairs
1. Study design (protocol & SAP/methodology)
2. Medical monitoring
3. DSMB & adjudication committee management
Scientific Affairs
1. KOL engagement
2. Publication development
Program Development
Program feasibility/risk/gap analysis
Indication analysis
Structured benefit-risk analysis
Unmet need & public health impact analysis
Epidemiology
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