Strategic Support for Your Drug Development in Asia
Through working in strong partnership with our clients, our strategic and regulatory affairs consultants provide assistance with drafting global development strategies for Japan, responding to inquiries from Japanese authorities, preparing drafts of application documents and corresponding with competent authorities to obtain marketing approvals in Japan. As the largest Regulatory Consulting Group in Japan, we offer more than 25 years of accumulated knowledge and know-how to support building strategic clinical development plans and detailed clinical trial protocol designs, and the relevant documents such as IBs and ICFs that are fit for Japanese trials. Our consultants can provide flexible support for special needs in collaboration with different groups sitting close by, such as development of strategic plans for combination products with Medical Device / IVD consultants, and preclinical consultants. Our drug development consultants can lead clinical development planning in almost all therapeutic areas.
Our Edge in Product Development Consulting
Strong Product Development Capabilities with Extensive Expertise
- CMIC can assist with product commercialization by applying our one-stop service covering all value chains and supply chains from product development, manufacturing, and to distribution. We apply our accumulated expertise in speedy and high-quality product development for our client’s commercialization needs.
- International capabilities to work for biopharmaceutical customers, whether they are in the US or Europe. CMIC consultants can handle small molecules, proteins and antibodies (tablets, ointments, and injectables).
Extensive Experience as a CRO
- CMIC consultants with professional expertise in various therapeutic areas can offer prompt consulting services in collaboration with CMIC clinical team, whose experience covers a wide range of therapeutic areas across almost all indications.
Accumulated Knowledge and Know-How
- Japans’ largest regulatory consulting group with over 25 years of experience supporting strategic planning and detailed clinical trial protocol designing
- High-quality CSR/CTD documentation in collaboration with Medical Writers who work in the same division within CMIC
- Can grasp state of the art information through strong networks with external professionals and through communications with competent authorities.
- Gap analyses
- Strategy development / research
- Drafting studies and designing protocols with relevant documents such as IBs and ICFs
- Patient Report Outcome queries and their usage for analysis
- Healthcare policy consulting, including Health Technology Assessment (HTA)
- Drug price consulting for reimbursement; NHI pricing negotiation strategies, explanation of calculation rules and methods, estimation of price for new drug with some assumptions, and supporting preparation for drug price negotiations with competent authorities.
- Legal consulting: Pharmaceutical Affairs Law and other related laws, regulations, and notifications
- GMP consulting, including manufacturing control of pharmaceuticals and investigational products, quality control and validation, and foreign manufacturer accreditation for manufacturing to export your commercial products to Japan