Strong support for any administrative procedure related to regulatory affairs
Strategic and accurate planning for pharmaceutical affairs in the early phases of development minimizes the time and cost required for product licensing. CMIC also increases the chance of approval by minimizing the risk of claims after application.
Support in the earlier phases of development is the key to successful licensing.
Reliable performance and expertise promise multi-perspective support services.
- Inside and outside network of specialists
- CMIC has a wide network of professionals in pharmaceutical affairs, medicine, pharmacy, pharmacology, toxicology and quality control, providing services from every aspect.
- Review by professionals
Medical (prescription and nonprescription), diagnostic and quasi-drug products
- Support for clinical trial consultation items for authorities, preparation of documents for submission, electronic submission of application forms of clinical trials and meeting records
- Planning of pharmaceutical affairs strategy
- CTD preparation (including electronic file preparation)
- Preparation of materials required for sales application
- Preparation of answers to various inquiries
- Preparation of various business license applications
- Support for quality control-related affairs
- Domestic clinical trial management
- Support for communication with authorities from application to approval
- Consultation with relevant authorities, including the Ministry of Health, Labour and Welfare of Japan
- Support for Drug Master File (DMF) Registration
- Response to inquiries from authorities
