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CMC Services

Our CMC department focuses on establishing large-scale synthetic routes along with formulation development and quality control, our drug categories can be proprietary drugs or generic drugs. All studies are complied with ICH and SFDA guidelines.

Feasibility study 

  • Project planning

Synthesis


  • Establish synthesis
  • “Freeze” the synthesis
  • Establish large-scale

Formulation Development


  • Pre-formulation testing
  • Formulation development
  • Process optimization
  • IVIV correlation
  • Scale up

Analytical Development

  • Establish HPLC methods for API, impurities, isomers and drug product 
  • Develop HPLC method for stability testing 
  • Conduct HPLC method validation 
  • Set API and drug product specifications

Stability Study

Perform stability study for API and drug product under ICH & SFDA guidelines

Regulatory Submissions

  • Prepare documentation for regulatory submissions
  • Prepare supporting documentation and data package

Our CMC experts with decades of experience are familiar with various ICH and SFDA regulations and guidelines, and have helped many clients completed their pre-formulation and formulation studies to provide reliable data for the regulatory submissions. We have already successfully assisted many clients completed the 1.1 class, 3.1 class and 6 class new drugs for SFDA application.
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