Tel:+81-3-5843-8480 Tokyo office
Tel:+81-78-219-4626 Kobe office
Services: Pharmaceutical Product Solutions

Pharma Training consultants have extensive experience in the area of pharmaceutical product development, and will work with sponsors to obtain approval for their products. Our services include:
  • Consultation on pre-application for bio-scientific data and manufacturing technology of biopharmaceutical product before IND in Japan and a regulatory application
  • Preparation of investigators' brochure of biopharamaceutical product
  • Consultation on selection of galenical composition for new drug (Tablet, Capsule, Fine Granule, Liquid, Other)
  • Consultation on packaging methods
  • Consultation on English CMC Spec. & test methods
  • Preparation of NDA submission documents for pharmaceutical dosage form based on the results of clinical pharmacodynamic study