2. Services
  3. Regulatory Sciences
  4. Registration Application in Japan
  5. Development/Application Support Service for Pharmaceutical Products

Development/Application Support Service for Pharmaceutical Products

Pharmaceutical Applications

Sumika Chemical Analysis Service offers a range of support services for work related to pharmaceutical applications. We cover everything from consulting on testing to preparing application documents. Please contact us for details.

  • Consulting on development/application for pharmaceutical products/medical devices
  • Gap analysis between overseas application data and domestic application
  • Consulting on application strategies
  • Support for consulting with regulatory authorities (such as PMDA)
  • Other items related to pharmaceutical product regulations
  • Applications for manufacturing and sales approval
  • Support for preparing CTDs and other application materials
  • Review/QC for application materials
  • Support for matters of inquiry from regulatory authority

Registration / Management of Overseas Drug Master Files (DMF)

  • Preparation support and registration for DMF registration materials
  • Maintenance/management of registered DMFs
  • Other related procedures

Contact Us for Services

For inquiries and requests concerning services of analysis, measurements, products and consulting , please feel free to contact us via inquiry form or telephone/fax .