REGULATORY CONSULTING

KMG Japan consults on MHLW (Japan’s Ministry of Health, Labor and Welfare or kosei-roudou-sho) regulations, the Drugs, Cosmetics & Medical Instruments Act, and regulatory application procedures for client companies; this has become a solid part of the business performance of the company.  KMG Japan’s key principal, Kyle Murphy, has personal and professional relationships with most of the key industry and regulatory officials in Japan. During the last 30 years, he has successfully helped many U.S. and Japanese companies launch their products by overcoming the most complicated regulatory issues.  KMG Japan has established a solid record of achieving regulatory victories for clients.

The Japanese market still differs noticeably from Western markets in many aspects of the regulatory area and continues to undergo significant changes.  KMG Japan works with its clients to recognize the differences up front and to include them in business decision-making.

KMG Japan can provide market research for its clients covering issues such as:

• Regulatory briefings
• Protocol development
• Creation of approval strategy for efficient process and maximized
  reimbursement price
• Troubleshooting when something goes wrong
• Sanity check on regulatory issues when dealing with your subsidiary
  or partner