Help Product Development Teams or Pharmaceutical Business Partners to figure out how to turn Regulatory Information or data into the basis their actions for desirable outcomes in their business.

• Support Global Product Strategy development driven by
  Japan　Regulatory Strategy and Implementation plan
  reaching out to Global Strategy.
• Support all communications with Japan Regulators fo
  PMDA Consultation, CTN or NDA representing the company
  having no office in Japan
• Assist in the execution (Organizing PMDA Consultation /CTN
  filing process / PV Safety Reporting ) of the regulatory
  strategy for the company’s development program
• Serve as the primary point of contact with the PMDA
  in Japan and other Asian territories representing a
  pharmaceutical company
• Design and implement for CROs to ensure the lean operations
  in line with Japan regulatory compliance
• Serve adaptive liaison- roles for pharmaceutical company to
  start Japan operations in terms of successful development
• Support to develop sourcing strategy for development in
  Japan operations
• Provide regulatory expertise in Due Diligence process to select
  an enabling Contract Research Organization
• Support to access Japanese KOLs in Medical Science & Technology
  of the area of pharmaceutical company’s interest
• Clinical Site Selections and CROs Management including Clinical
  site access in Japan.

Pharmaceutical Companies in US

• Assist in the execution (Organizing PMDA Consultation /CTN filing Process / PV Safety Reporting ) of the regulatory strategy for the company’s development program
• Serve as the primary point of contact with the PMDA in Japan and other Asian territories representing a Pharmaceutical Company
• Design and manage Training program for Regulatory Scientists
• Support to develop Regulatory Strategy & Plan Document for entire Japan portfolio in Regulatory Affairs
• Support CRO and CSO selection by Due Diligence and CRO management including Clinical site access in Japan.



Contract Research Organization in Japan

• Support Pre-marketing strategy development of Benefit /Risk Assessment toll and Business Development

Contract Sales Organization in Japan

• Support Business Development and Business Transformation to CRO

Site Management Organization in Japan

• Serve as a board director
• Support New Business Development strategy