Message from the CEO & Introduction of Consultants

CEO’s Message

Comprehensive Support Covering All Aspects from Talent Development to Field-Level Operations

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

Specialized Consultants / Career Backgrounds

CMC Regulatory Affairs	Head of CMC Regulatory Affairs at a major foreign pharmaceutical company (New drug development to post-marketing change management).
Epidemiology & Clinical Statistics	Clinical 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-Clinical	Research 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 Devices	Medical 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 Writing	Clinical 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 Consultant	General 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).
Distribution	Head 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 Pricing	Public Affairs at a major foreign pharmaceutical company (New drug pricing strategy development (acquisition of usefulness addition), drug price negotiations, insurance reimbursement).