Message from the CEO & Introduction of Consultants

CEO’s Message

Our world is constantly changing with the advancements in healthcare. Particularly in pharmaceutical development, we have witnessed remarkable evolution from chemicals to biologics and further to regenerative and cell therapies. CUES Consulting stands behind our clients at the forefront of these dynamic changes, contributing to the growth of the healthcare industry.

We offer a wide range of services, including development regulatory affairs, pharmaceutical regulation, CMC regulatory affairs, Pharmacovigilance, and post-marketing surveillance. All these services are supported by professionals with extensive experience in the pharmaceutical industry. Our expertise and experience are utilized to fully support our clients from the development of pharmaceuticals to their market introduction.

CUES Consulting aspires not just to follow the changes in the medical industry but to be a leader in these changes. Our mission is to provide new hope and treatment opportunities to patients through innovative medical solutions. We are committed to our daily operations with this purpose in mind.

Representative Director of CUES Consulting Inc.
Motoyuki Takano

Introduction of Consultants

Motoyuki Takano

Representative Director, CUES Consulting Inc.


  • Streamlining pharmacovigilance organizations
  • Planning safety assurance measures
  • Transferring safety data at the time of succession
  • Creating risk management plans
  • Planning global safety measures

Career History

  • Daiichi Pharmaceuticals: Sales Planning, Clinical Development Project Leader
  • Wyeth: Clinical Development Project Leader
  • Sanofi: Clinical Development Project Leader, PV Database Management
  • Shire: Head of Pharmacovigilance, Safety Manager
  • Ferring: Head of Pharmacovigilance, Safety Manager, Post-Marketing Surveillance Manager
  • Medtronic: Head of Clinical Trial Safety Management, Safety Manager

Takashi Yoshida

Chairman of CUES Consulting Inc.


  • Regulatory affairs strategy (development, post-marketing regulatory affairs)
  • Corporate risk management
  • Mergers and acquisitions, product succession

Career History

  • Fujisawa Pharmaceutical Co., Ltd.: Clinical development, Head of Development Regulatory Affairs, US Project Management
  • Astellas Pharma Inc.: Head of Development Regulatory Affairs
  • Sanofi: Executive Officer, Head of Regulatory Affairs, Head of Pharmacovigilance, Head of Reliability Assurance, Head of Regulatory Affairs for Japan-Pacific Region, Overall Manufacturing and Marketing Manager
  • GlaxoSmithKline: Director of Regulatory Affairs, Head of Public Affairs, Overall Manufacturing and Marketing Manager

Specialized Consultants / Career Backgrounds

CMC Regulatory AffairsHead of CMC Regulatory Affairs at a major foreign pharmaceutical company (New drug development to post-marketing change management).
Epidemiology & Clinical StatisticsClinical statistics at a major domestic pharmaceutical company (Statistical analysis in new drug development), Epidemiological research and post-marketing clinical trial planning at a major foreign pharmaceutical company.
Non-ClinicalResearch institute of a major domestic pharmaceutical company (New drug discovery), Global project leader (International joint development), Institute director, Business development for domestic venture businesses (Introduction and export of seeds).
Medical DevicesMedical Device Institute, Factory Quality Control and Assurance, Regulatory Filings (General Medical Device Notifications, Controlled Medical Device Certification Applications, Medical Device Manufacturing Licenses, etc.), General Marketing and Manufacturing Manager, Quality Assurance Manager, Responsible Engineer.
Medical WritingClinical development at a major foreign pharmaceutical company (Monitoring, clinical plan formulation), Medical writing, Application document preparation (CTD editing), Medical affairs (Post-marketing clinical trial planning).
Global Business ConsultantGeneral Manager at a major foreign pharmaceutical company (New market entry, resource management, corporate integration & business divestiture, new product launch, partner business promotion, organizational design & sizing & talent acquisition).
DistributionHead of distribution department at a major foreign pharmaceutical company (Distribution schemes, distribution function construction for new market entry business, 3PL setting, proposing the best distribution form according to product characteristics, transitioning the profit system to wholesalers from a margin business to a Pay for Performance fee business).
Drug PricingPublic Affairs at a major foreign pharmaceutical company (New drug pricing strategy development (acquisition of usefulness addition), drug price negotiations, insurance reimbursement).

Collaboration with External Companies

Domestic medical writing company (CTD document preparation), drug pricing consulting firm (Drug pricing strategy planning for pharmaceuticals, medical devices, regenerative medicine products, drug pricing application preparation, drug pricing negotiation representation), electronic application document preparation company (CDISC, Gateway compliance), etc.

Inquiries & Consultations Are Free.
Please Contact Us.

24-hour acceptance.

Contact Us

A specialist will respond promptly to your inquiries.