Integrated CMC Platform

Our Superiority

• End-to-End Integrated Services

  ◆ Integrated CMC at Xihua Pharma– API process & manufacturing, formulation dev & clinical formulation manufacturing, analytical & regulatory filing
  ◆ Integrated IND at Xihua - Pharmacodynamics, Pharmacokinetic, Safety Assessment, CMC, and Regulatory Affairs
  ◆ Shorten the development cycle, expedite the IND application/improve the success rate of generic drug BE, and reduce the overall cost
  

• Experienced Team Members

  ◆ Core members from world-renowned innovative as well as generic drug companies in U.S. and China, and being responsible for the development of numerous innovative drug and generic drugs for FDA/NMPA/EU/WHO registrations
  ◆ Proven track record in API and formulation development, scale up, production and/or technology transfer, and analytical method development and validation
  

• Efficiency, Quality & Project Management

  ◆ Comprehensive quality assurance system and strict compliance requirements
  ◆ Equipped with the advanced, full array of instruments and equipment, to ensure high quality and high efficiency of the development
  ◆ Core team members are responsible for project management to achieve the best customer experience.