ONE-STOP SERVICE FOR DRUG DEVELOPMENT

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One-stop service for drug development
  • Development of API and drug product which meets the registration requirements CFDA or FDA
  • CTD format application
Technical services
  • One-stop service for drug development
  • Quality studies of API and drug product
  • Prepare CTD format document
API development
  • API structure confirmation
  • API analytical method development and validation
  • API physicochemical properties characterization
  • Study of polymorphism of API
  • API stability test
  • API specification establishment
  • CTD format document preparation
Drug product development
  • Testing for API and excipients
  • Drug product method development and validation
  • Compatibility study of API and excipients
  • Process development of formulations
  • Compatibility study of package materials
  • Stability test for drug product
  • Drug product specification establishment
  • CTD format document preparation