Rich experience in biologics drug regulatory affairs, successfully received marketing authorization and IND approval for several products.
Familiar with Chinese, EU and US health authorities’ guidelines and application process, able to provide comprehensive drug development strategy support for products
Excellent strategy formulation and regulatory affairs capabilities to quickly promote the product go-to-market process in a compliant way
Sound communication and exchanges with drug regulatory agencies to effectively solve key regulation issues
High-quality product life cycle registration management, clear sorting and maintenance of product files
Professional and veteran team members are, with 10+ successful IND and BLA programs
— Production schedule and CDE review appointment
— Production preparation｜Bulk production Formulation production｜Bulk production Formulation production
— Send samples to NIFD for testing
Rich experience in biologics drug regulatory affairs
Familiar with Chinese, EU and US health authorities’ guidelines
Excellent strategy formulation and regulatory affairs capabilities
Sound communication and exchanges with drug regulatory agencies
High-quality product life cycle registration management
Professional and veteran team members
— Production schedule and CDE review appointment
— Production preparation｜Bulk production Formulation production｜Bulk production Formulation production
— Send samples to NIFD for testing
