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Preparation of approval application and related consulting services
Based on our long-term experience and expertise, we prepare application for approval including import, manufacture and foreign manufacture, and provide related consulting services. We provide services in detail, from preparation of approval application to attendance at submission of application.
• Preparation of approval application for import, manufacture, and foreign manufacture
• Making a list of documents necessary to prepare approval application in Japanese and/or English
• Establishing specifications and test methods in accordance with release tests at foreign manufacturer
• Coordination of testing such as physical, chemical, electrical, and biological tests
• Support for communication and negotiation with overseas manufacturers
• Preparation of responses to deficiency letters from PMDA and related communication
• Attendance at submission of application to a local government
