Comprehensive development support from early-stage strategic planning to regulatory approval
In Japan’s clinical development environment, we frequently encounter challenges, including determining the applicable regulatory requirements, managing PMDA consultations, and harmonizing global study protocols with Japan‑specific requirements.
Micron has a dedicated team of experts well versed in Japanese regulatory requirements, including the Pharmaceuticals and Medical Devices Act (PMD Act), the GCP Ordinance, the QMS Ordinance, and the Clinical Research Act. We provide practical support tailored to each stage of development for pharmaceuticals, medical devices, and regenerative medical products, from early‑stage development strategy and PMDA consultations to clinical trial notifications and marketing authorization applications.
We provide comprehensive support from the initial assessment phase through to the practical application procedures—providing flexible, tailored assistance at every stage.
Development Support Workflow
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Early Development
- Development and Market Entry Strategy for Japan
- Assessment of Regulatory Requirements and Gap Analysis
- Protocol Development Support
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Clinical Trial Plan
- Strategic Planning for PMDA Consultations
- Prepare consultation materials
- Assistance with regulatory authority interactions
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Clinical Trial
- File the CTN, CTN amendment
- Response to regulatory inquiries
- Documents preparation support
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Clinical Trial Application
CTA- Application form and approval CTD/STED
- Preparing to respond to inquiries
- Application Strategy Consulting
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Clinical Trial Notification
CTN- CTN Submission support
- Addressing the review
- Response to regulatory authorities
Support for collaboration in medical writing, data management, and statistical analysis.
Solutions
Contact Us
If you are considering regulatory consulting, please feel free to contact us.
Please feel free to contact us
We provide comprehensive, end‑to‑end clinical development support, with imaging at its core.
With more than 20 years of experience, our team of imaging specialists in Japan and around the world tackles the complex challenges of imaging evaluation in pharmaceutical and medical device development. We deliver optimal, project‑specific solutions for each client.