Your full-service partner for entering the Japanese market
The drug development landscape, regulations, and systems have been changing rapidly. It is essential to have a partner who can develop strategies while staying informed about trends among regulatory authorities.
CMIC is your strategic consulting partner for navigating today’s rapidly evolving clinical development landscape. With deep regulatory insight and decades of experience, we work with you to achieve efficient and reliable progress from development to commercialization.
-
Appx. 200
Consultants
& Medical Writers -
150+
(past 5 yrs)PMDA consultation
-
Appx.170
(past 5 yrs)CTDs
(including CMC modules) -
Appx.70
(past 5 yrs)Drug pricing consulting
Clinical Development Strategy
We support market entry into Japan through development strategy planning, gap analysis, and consultations with the PMDA. Based on your development stage and business objectives, we propose strategies aligned with current regulatory expectations, including global trial designs covering Japan and other Asian countries and assessments of the need for Phase 1 studies in Japan.
With experience in orphan drug designation, Cartagena Protocol applications, and the Sakigake Drug Designation System, we help develop approval strategies tailored to the specific regulatory frameworks and characteristics of each program.
- Development Strategy Consulting
- CMC Consulting
- Gap Analysis
Regulatory Consulting and Medical Writing
Our team of approximately 100 medical writers—one of the largest in Japan—supports the preparation of a wide range of regulatory documents, including CTDs (covering CMC and non-clinical sections), clinical trial protocols, investigator’s brochures, and informed consent forms.
By ensuring alignment with both global guidelines and local regulatory requirements, and working closely with internal experts and external partners, we enable reliable and practical regulatory support that helps advance development toward approval and commercialization, even in complex regulatory environments.
- CTD preparation (covering all parts, including CMC)
- CSR preparation
- Preparation of clinical trial-related documents (Investigator's Brochure, Protocol, Informed Consent Form, etc.)
- Response to inquiries from regulatory authorities
- Document preparation in accordance with SOPs and templates
Commercialization and Access Strategy
CMIC’s consulting team specializes in drug pricing and supports the development of feasible strategies by evaluating regulatory trends, product characteristics, and product lifecycle to clarify a product’s value proposition.
Furthermore, through collaboration with the CMIC Group, we can support end-to-end business strategy consulting to maximize the value of our clients’ products.
- Drug Pricing Consulting
- Market Access Strategy
- Support for Obtaining Certification as a Foreign Manufacturer
Consultant
Experts in regulatory consulting, CMC regulatory affairs, and drug pricing work closely with clients to provide practical regulatory support aligned with country specific regulatory requirements throughout the development lifecycle.
- Consultation with the PMDA
- Drug Pricing Consulting
- CTD Preparation
- CMC
- ODD Applications
-
Professional background
Managed a biostatistics department at a major foreign pharmaceutical company for over 20 years. As a biostatistician, engaged in global development, formulation of clinical development strategies in Japan, PMDA consultations, and regulatory submissions and interactions with authorities for many years. Also responsible for new drug development in areas such as cardiovascular, inflammatory, and cerebrovascular drugs, antibiotics, and blood products. Ph.D. (Medicine).
Specialties
Biostatistics. Consulting on global drug development and clinical development strategies.
-
Professional background
Over 20 years of experience in project management and regulatory affairs in the development and regulatory departments of a foreign pharmaceutical company. Later spent approximately 10 years in the drug pricing department, where I was involved in drug pricing-related tasks for 13 new drug products. Since joining CMIC, I have supported the listing of numerous drugs and provided consultation on estimated drug prices for more than 10 active ingredients in development.
Specialties
Drug pricing-related services
-
Professional background
After working in the medical science and licensing department of a foreign pharmaceutical company, I was responsible for all aspects of regulatory affairs (including marketing authorization applications, new business license applications, and interactions with regulatory authorities) at a Japanese affiliate. I have also been involved in drug safety information management and post-marketing surveillance. Since joining CMIC, I have been responsible for consulting on the acquisition of manufacturing licenses and providing in-person consultations. My work is primarily responsible for preparing Module 1 and 2 for a Marketing Authorization Application (MAA). Rich experience in CTD preparation spans more than 20 years.
Specialties
Drafting of package inserts and Risk Management Plans (RMPs)
Other – Group Consulting Capability
The CMIC Group has established a comprehensive framework capable of covering all aspects of pharmaceutical and medical device development, from upstream to downstream. This enables us to provide a wide range of consulting services beyond those mentioned above, including market analysis, non-clinical consulting, and bio-CMC consulting.
Please visit our group website for more details.