Pharmaceutical Sciences
Pharmaceutical Sciences is responsible for the pharmaceutical development and manufacturing of clinical candidates.

• Process research and development for clinical supply manufacturing
• Formulation development
• Analytical method development/validation
• Formulation development
• API and drug product manufacturing
• Drug quality studies
• Drug stability studies and product shelf life determination
• CMC regulatory filings

Clinical and Regulatory Affairs
Clinical and Regulatory Affairs is responsible for clinical program design and operation, as well as registration of IND with China SFDA, the US FDA and regulatory agencies in other countries.

Clinical Development
• Global IND filing and clinical trial management
• Strategic planning for new drug development
• Clinical program design, study management and execution
• Compliance with GCP and ICH guidelines
• Liaison with medical experts worldwide

Regulatory Affairs
• Communication with regulatory authorities (FDA and SFDA)
• Compliance with drug registration requirements of China and the global
• Maintenance and archive of documents and correspondence
• Clinical program support and strategic advice