Our Services

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Preclinical study (CMC)

  • Process design and screening
  • Verification of process parameters, safety and quality attributes
  • Preparing of IND filing batch and IND filing support

Clinical stage

  • Technical transfer
  • Process optimization for COGS, Starting materials and Process Robustness
  • Production of clinical API
  • Stability study

NDA filing support and commercial

  • Kilogram to multi-Ton full scale production
  • NDA filing support
  • Long-term stability study
  • Continuous optimization