Opening up a challenging horizon for strategic and
streamlined product development plans in Japan.
Broadening an exciting new frontier for the efficient will or
choice of development options in Japan.

Optimized Strategic Approaches toward the Integration of Japan into Global Drug Development Scenarios leading to Shortened Development Period

QiPharma R&D Japan assists clients:

• To preliminarily explore the feasibility of developing/ marketing a candidate product
• To build initial development strategies and submission logics based on:
• Delineation of product positioning
• Approach to the primary source re. epidemiology, therapeutic algorithm, market size, etc.
• Detailed gap analysis according to MHLW^*1 non-clinical assessment requirements
• Ethnic sensitivity analysis (medicine’s sensitivity to ethnic factors)
• To review IB and protocol, translated into Japanese, from a scientific and technical perspective (Japanese wording characteristic of R&D)
• To conduct surveillance of MHLW - ICH^*2 circular notices/ GLs, and medical associations and JPMA^*3 information
• To craft scientific rationale for successful development in coping with the views of MHLW or academia

*1 Ministry of Health, Labor and Welfare

*2 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use

*3 Japan Pharmaceutical Manufacturers Association

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QiPharma R&D Japan addresses cross-cutting issues on demand.

• To give practical counsel on development-related issues from time to time
• To undertake a consultancy assignment in a given period
• For pursuing a variety of roles and functions for Japanese specifications
• For supplying 'second opinions' on plausible development scenarios or documentation from internal and/or external sources