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1. Comprehensive support for clinical development
1)
By fully utilize our in-house functions of planning development strategies and conducting clinical studies, we are able to conduct clinical development comprehensively from designing development plan to conducting clinical studies, preparing for NDA, and upon request, applying for NDA, corresponding to PMDA after NDA, obtaining approvals, which are based on sophisticated strategies that are proactive in drug pricing and marketing.
2)
Clients are able to outsource not only a comprehensive package of drug development, but also individual tasks. Upon request, we support and entrust tasks such as plan, conduct, management and observation of non-clinical/clinical studies. We can provide versatile services for individual tasks such as temp service for monitoring on clinical studies and technical consulting on a certain area.
3)
Our experts who have experienced and achieved many accomplishments at major Japanese or foreign affiliated pharmaceutical companies, will develop a new plan questing for high efficiency. Our function is equivalent to or surpasses the one in major pharmaceutical companies in view of quality, so this is operated much more efficiently because of its compact size and high mobility.
2. Partnering
1)
We in-license drug candidates from domestic/foreign bio-venture companies and pharmaceutical companies
2)
We conduct a pre-clinical study based on development strategy/plan for drug candidates, and promote partnering with pharmaceutical companies in Japan by adding values to compounds.
3)
Basically, we co-develop with a licensor sharing risk and profit of the development.
About TSD Japan
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