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Pharmaceutical Research
Innovative Drug Process Study & Filing

Innovative Drug Process Study & Filing

We provide API process development, optimization, manufacturing, and filing services, based on IND requests in preclinical and clinical phases.

  • Customization of initial materials
  • Synthetic process research
    Route design and determination Process optimizationOptimization of key process parametersEstablishment of quality standards for raw materials, intermediates, and finished productsEstablishment of central control standardsImpurity profiling Preparation (or purchase) and standardization of impurities/standard samplesPreparation and standardization of API standard samplesPreparation and standardization of raw materials and intermediate standard samples Impurity standard samples (preparing or purchasing of impurities; structure identification and standardization if necessary, with impurity content of 10mg-500mg) batch for laboratory-scale test One batch for safety evaluation (for toxicology research, non-GMP) One batches for pilot-scale tests (for pilot-scale test (non-GMP)) Two batch for GMP evaluations (production based on cGMP) One
  • Quality study
    Development of draft material quality standardsDevelopment and optimization of analytical methodsMaterial inspection and releaseCentral control analysisVerification of analytical methods
  • Stability study
    Influencing factors (1 month)Accelerated stability (6 months)Long-term stability (24 months)
  • Selection and development of form process
    Selection of crystal formResearch on the form process
    Generally, we use X-ray powder diffractometers (XRPDs) to determine the crystal form in multi-form analysis.
  • Compilation and writing of filing materials based on IND
    Reports and materials:
    Process optimization reportsPilot-scale test reportsMethod verification reportsStability reportsFiling materials in CTD format, etc.
Relevant laboratoriesRelevant laboratories
  • Analytical Instruments
  • Analytical Instruments
  • TGA
  • pre-HPLC
  • Process instrument
  • Process Safety Instruments
  • API production workshop
  • UV spectrophotometer
  • Ultraviolet spectrophotometer
  • Turbidimeter
  • Panorama of liquid and mass analysis
  • New generation medicated impactor
  • Fourier infrared
  • Melting point meter