Pharmaceutical Research

Pharmaceutical Research

API process route selection and optimization

We provide process route screening services according to various requirements, including innovative process route selection for generic drug, innovative drug process route development, ect.
Services for QTPP’s & CQA’s determination according to various product development requirements, CPP’s determination according to DOE experiments; Services for Pre-PPQ batch manufacture and process validation in compliance with CFDA’s & FDA’s regulations.

Innovative drugs

  • Starting material-based synthetic route selection
  • RSM-based route selection
  • Cost-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)

  • Service Hotline


  • Email

    We will give you reply as soon as possible.

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