1. Pharmaceutical Consultant 2. Solutions for concerns regarding the import and storage of overseas medical devices
Holding qualifications for manufacturing and sales (D-MAH) as well as manufacturing! We handle everything from the import to distribution of overseas medical devices! We provide comprehensive support from notification to storage!
We provide support services as a Manufacturer and Marketing Authorization Holder (MAH), Designated Marketing Authorization Holder (D-MAH), and Manufacturer (Storage) for overseas medical device manufacturers. ◎ On behalf of overseas medical device manufacturers aiming to enter the Japanese market, we will handle notification and registration tasks. 1. We will apply for permits and notifications to the PMDA/Ministry of Health, Labour and Welfare on behalf of foreign manufacturers. (Foreign manufacturers can directly submit marketing notifications as the notifier. We will assist with this.) 2. We will act on behalf of foreign manufacturers for their manufacturing registration tasks. 3. We will handle correspondence with authorities regarding QMS/GVP. 4. We will respond to the Ministry of Health, Labour and Welfare/PMDA/prefectures. "Third-Class Medical Device Manufacturing and Sales License Number: 28B3X10031" ◎ As a manufacturing registration holder (storage), we will store your medical devices. 1. Temporary storage of imported medical devices (advanced medical devices, controlled medical devices, general medical devices) 2. Please use our warehouse for the packaging, labeling, and storage of your medical devices. We provide comprehensive support from import to distribution. We also accept inquiries regarding pharmaceutical affairs, so please feel free to contact us if you have any questions. *For more details, please download the PDF.
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【Features】 ■ 10 years of experience as a regulatory consultant ■ Consulting for over 30 companies ■ 30 years of experience and achievements in the industry ■ For those who wish to "manufacture and sell medical devices," "import and sell medical devices," or "sell functional foods" 【Support Content】 ■ Development strategy planning and regulatory consulting for medical devices and in vitro diagnostic products ■ Support for approval and certification applications for medical devices and in vitro diagnostic products ■ Assistance in obtaining manufacturing and sales licenses for medical devices ■ Support for approval applications for quasi-drugs ■ Sales support for functional foods, etc. ■ Support for approval applications for regenerative medicine products ■ Training on practical application form preparation * Please download the PDF for the application form.
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Please download the application form as a PDF.
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Our company provides consulting services for medical devices and related regulatory affairs, including regulatory consulting for medical devices, pharmaceuticals, and in vitro diagnostic products. With extensive experience and a proven track record, we offer regulatory consulting for applications related to medical devices, in vitro diagnostic products, and other bioproducts, ensuring accurate and prompt responses for various PMDA pre-consultations, inquiries, and the preparation of application documents and STED. Additionally, we support the creation of procedures related to manufacturing and marketing under ISO 13485 and other business acquisitions based on precise advice. Please feel free to consult us if you have any requests.