Clinical Development
Our support covers the
following aspects:
Identification and selection of Japanese KOLs. Development of communication and engagement plan with KOLs.
- Develop clear understanding of Unmet need/Medical practice in JP
- Suitable Clinical positioning of the drug in Japan
- Commercial insights
- Support during PMDA consultation
Regulatory and Clinical Development Strategy for Japan
- Yakumed will build a detailed independent assessment report including recommendations and potential risks
Support and maintain the relationship with Japanese KOLs and relevant Patient Advocacy Group(s) in Japan
- Support includes all areas related to orphan designation (Strategy, Preparation of Docs and F2F meetings with MHLW).
Support referral to study sites to boost recruitment
- Exploring eligibility for conditional approval, Strategy, Preparation of Docs and F2F meetings with PMDA. Etc.
We are your gateway for success in Japan
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