Tel:+81-3-5843-8480 Tokyo office
Tel:+81-78-219-4626 Kobe office
Services: Regulatory Strategic Solution

Pharma Training consultants will create and offer a regulatory strategic plan and promote clinical trials for approval of your products in Japan.

First, we create a Regulatory Affairs Strategy which addresses key issues such as:
  1. What is the positioning of your product (or service) in Japan's medical environment?
  2. Is your product innovative, filling an unmet medical need?
    • Patients' need
    • Medical need
    • Clinical efficacy/evidence
    • Safety
    • Insurance/Reimbursement
  3. Marketability in Japan?
  4. Clinical Trial Feasibility (if Japan trial)?
  5. How we can use the study results obtained outside Japan for approval?
Then, we create a Strategic Plan with a Clinical Protocol Outline to submit to Japan's Regulatory body. We consult on:
  • Japan Pharmaceutical Affairs Law
  • Japan GCP as well as ICH-GCP
  • GLP and GQP/GMP
  • Guidelines and Japanese notification