We offer comprehensive regulatory support in line with current requirements of the regulatory authorities to clients who are considering pharmaceutical regulatory development of cell and tissue based medicine in Japan
Documentation and application support in accordance with Japanese regulatory trends
Expectations for regenerative medical products and cell and tissue based medicine is growing significantly worldwide.
In Japan, the revised Pharmaceutical Affairs Law has been enacted with an intention to shorten drug development period, and regenerative medicine is being driven as a national commitment. On the other hand, the Regenerative Medicine Law has been enacted, and regulations in terms of safety for private practice of regenerative medicine that has not been approved are being tightened.
We offer consultation and document preparation support by specialists who have deep knowledge of regulatory affairs, including preparation of information packages for consultation with the regulatory authority at each stage of development, and preparation of notification and application materials.
Examples of services for application for drug manufacturing/marketing approval
- Preparation of information packages for consultation with the regulatory authority, development consultation support
- Preparation of notifications and new drug application materials, translation of technical documents
- Corresponding with PMDA (Japanese regulatory authority) as your agent in Japan
We know the Japanese regulatory environment for cell and tissue based medicines. Our experts look forward to talking with you about your needs and recommended courses of action.