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.