The

The Insight Company | Japanese Medical Regulatory Consulting

Japanese Medical Regulatory Consulting

for foreign manufacturers of drugs, quasi-drugs and devices

外国製造会社のための薬事関連業務の援助

薬 事

 

  • Foreign Manufacturer Accreditation (FMA)
  • Quality System Audit, QMS & GMP
  • Regulatory Research & Support
  • Technical Translation

 

 

Product Registration

  • Shonin: Pre-Market Approval
  • Ninsho: Certification by Notified Body
  • Notification

 

“We are focused on the goals of our clients, sensitive to their business needs, and committed to teamwork, which is required for a successful regulatory submission to the Japanese Ministry of Health, Labor and Welfare.”

The Insight Company is located in the greater Seattle area.

Contact Sayoko Kuwahara at kuwahara@insight-company.com

The Insight Company