Clinical Pharmacology

•Program Development Strategies (Defining and outlining studies needed for          Regulatory Filings)

•Protocol Development for Phase 1-4 studies

•PK\PD data analysis and interpretation

•Report Writing

•Investigator Brochures

•Preparation of Clinical Pharmacology Sections for Regulatory submissions             (INDs, NDAs, BLAs, Labeling)

•Regulatory Interactions (US, Europe, Japan)

•Abstracts, Manuscripts and Posters

•Due Diligence Reviews

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