Innovative Drug Process Study & Filing

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Service

• 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.

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