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Assistance with organization of Preclinical and Clinical trials (in compliance with FDA, EMEA, MHLW, OECD)

  • Provide assistance in designing preclinical and clinical trials
  • Discuss with EMA preclinical and clinical trials requirements (Scientific Advice)
  • Coordinate the preclinical and clinical program for EU Approval
  • Provide support for:
    • Cost analysis
    • Purchase of reference product
    • Country and CRO selection for running preclinical and clinical trials