Pharmaceutical study

Pharmaceutical research

API process route selection and optimization

PharmaResources provides process route selection services based on different needs, including generic drug innovative process route selection, innovative drug route development, etc. Based on product development requirements, we determine QTPP, CQA, key process parameters through DOE experiments, and provide process validation services for engineering batch production and compliance with CFDA and FDA.

Innovative drugs

  • Starting material-based synthetic route selection
  • Cost-based synthetic route selection
  • Quality control-based route selection

Generic drugs

  • Process patent breakthrough/innovative process route selection
  • Cost-based route selection
  • Generic drug process route selection

Highly active drug process selection and development

Process development

  • Meeting the needs of toxicology batch and clinical batch production and commercial production
  • DOE experiments for process characterization to determine operating parameter ranges
  • Process development based on Quality Risk Assessment (QRA), to determine critical process steps/parameters CPP/PAR/NOR
  • Process development for pilot test, process transfer, and process validation
  • Address

    Bldg. 12, No. 59 Kai Qing Rd, Pudong, Shanghai (West Campus)

    Bldg. 7, No. 509 Ren Qing Rd, Pudong, Shanghai (East Campus)

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