Specialist Fields

TEL 03-3355-1168

Medical Devices

Support for the Preparation of Regulatory Dossiers

  • Key points:
  • We can check data consistency by applying our practical experience and expertise.
  • We can help you avoid misunderstandings with the authorities and manufacturers by acting as a go-between.
  • We can handle urgent translations of inquiries from regulatory authorities.

Solution Case Studies

For clients selling an overseas manufacturer’s products in Japan, we:

  • Provide support for the preparation of regulatory dossiers
  • Provide Summary Technical Documents (STED) for overseas applications and prepare any relevant appendices
  • Prepare applications and STED drafts
  • Translate relevant appendices
  • Check for data consistency
  • Assist you in handling inquiries from regulatory authorities
  • Help you communicate with overseas manufacturers
Image: Support for the Preparation of Regulatory Dossiers