神戸バイオ・デバイス開発研究所 Company Profile

We have abundant experience and achievements, and we will respond to our customers with accuracy and speed!

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.