Services for US/EU Companies
Comprehensive support for market entry and clinical development in Japan, backed by deep knowledge of its regulations and culture.
- Clinical Development Strategy Consulting for Japan
Designing optimal trial strategies that reflect Japan’s unique regulatory environment, medical culture, and healthcare practices. - Provision of Local PM / CRA in Japan
Local clinical trial experts who manage trial progress, coordinate with sites, and ensure smooth communication among stakeholders. - Japanese Translation and Localization Services
Translation and localization of regulatory documents, informed consent forms, and patient-facing materials, meeting Japan’s pharmaceutical standards. - Preparation and Translation of Submission Documents for Japanese Authorities
Transforming English-based documents into PMDA-compliant submissions with accurate terminology, logical structure, and reviewer-oriented clarity to maximize approval potential. - Local Clinical Trial Network Building (Including KOL Identification & Interviews)
Selection of optimal trial sites and investigators, identification and engagement of Key Opinion Leaders (KOLs), conducting interviews and advisory boards to strengthen both scientific credibility and clinical feasibility. Leveraging KOL networks to accelerate patient recruitment and trial readiness. - Regulatory and Cultural Mediation
Acting as a bridge between Western and Japanese stakeholders to ensure seamless communication with authorities, CROs, and trial sites.
Our Commitment
- Practical strategies built on deep cross-cultural and cross-regulatory insight
- Agility through strong CRO alliances and provision of experienced local staff
- A balance of scientific credibility and clinical execution power
Delivering your innovative medicines to patients in Japan and worldwide – faster and more reliably.
HGMI Health will chart and execute that path with you.
