Leave the consulting for medical devices and functional foods to us!
Our company provides consulting services for medical devices and related regulatory affairs, including approval application processes for medical devices, in vitro diagnostic products, and functional foods. We also assist with STED preparation, consultations with PMDA, and responses to PMDA inquiries. Additionally, we support the acquisition of business types such as manufacturing and sales, preparation of standard operating procedures, manufacturing, ISO 13485, and sales. 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 STEDs. Furthermore, we provide support for the preparation of standard operating procedures and the acquisition of business types related to manufacturing, manufacturing and sales, and ISO 13485, based on precise advice. Please feel free to contact us if you have any requests. 【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." *Please download the application form as a PDF.
Inquire About This Product
basic information
【Support Content】 ■ Development strategy planning for medical devices and in vitro diagnostic products, regulatory consulting ■ Support for the preparation of approval and certification application documents for medical devices and in vitro diagnostic products ■ Assistance in obtaining manufacturing and sales licenses for medical devices ■ Sales support for functional foods, etc. ■ Support for approval applications for regenerative medicine products ■ Training on practical application document preparation *Please download the PDF for the application form.
Price range
Delivery Time
Applications/Examples of results
Please download the application form as a PDF.
Company information
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.
