コアメッド Company Profile

Consulting company for pharmaceutical regulatory strategy and development strategy.

Since our establishment, we have consistently adhered to the principle of "quality first," providing pharmaceutical and biopharmaceutical companies both domestically and internationally with services related to the construction and advice on regulatory strategies and development strategies, including data evaluation for new drugs and biopharmaceuticals in CMC, non-clinical, and clinical stages, as well as face-to-face consultations with PMDA, preparation of marketing authorization applications (CTD creation), and responses to inquiries, contributing to the prompt approval of new drugs. In recent years, we have also been offering development and regulatory-related services for regenerative medicine products. Please feel free to contact us if you have any requests.