our service
Regulatory Consultant
Service feature 1
Solutions Through Qualified Consultants and Broad Network
As regulatory professionals, our consultants work closely with medical device and regenerative medicine-related companies in Japan and overseas to provide appropriate advices.
•Regulatory consulting services for medical devices and regenerative medicines
•Marketing consulting services for medical devices and regenerative medicines
•Consulting services for the acquisition of ISO 13485 certification
Service feature 2
Comprehensive Consulting Services for Rehabilitation Equipment
We also provide comprehensive consulting for rehabilitation medical equipment. We can provide accurate advices on a variety of problems specific to the equipment in question. Please feel free to contact us.
Pharmaceutical Affairs Consulting Service List
Various Support from Development of Medical Devices to Preparation of Application Dossiers
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Medical device development and business plan construction consulting
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Consulting for manufacturing and marketing approval application strategy
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QMS application form preparation and application work support
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Clinical trial design construction support and clinical trial implementation management, etc.
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Consulting on biological safety assessment (biological guidelines)
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Consulting regarding inquiries from the Pharmaceuticals and Medical Devices Agency (PMDA), etc., and responses to expert councils
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Consulting on clinical development of medical devices
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Consulting on business licenses for Marketing Authorization Holder (MAH), Manufacturer, etc.
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Assistance for private importation of unapproved medical devices with doctor’s license
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Consulting on general regulatory affairs