For those who wish to develop and market new drugs or medical devices in Japan, CMIC can assist with regulatory strategic planning, negotiations with health authorities, documentation support, and support in the notification, accreditation, and approval processes. We are the largest consulting group in Japan consisting of more than 60 consultants with extensive experience.
CMIC's Edge in Consulting
Highly specialized consulting team
All CMIC consultants are talented professionals with specialist knowledge and a wealth of experience in their respective fields. Many of our consultants have 25 years of experience or more (e.g. R&D, manufacturing,and analysis) in pharmaceutical companies, and some have about 10 years of experience in regenerative medicine. Our highly experienced consultants from a wide range of fields will provide high-quality consulting services on diverse issues.
Consulting available on a wide range of regulatory-related issues
We can assist in making inquiries to regulatory authorities, including the Pharmaceuticals and Medical Devices Agency (PMDA) and the Japan Ministry of Health, Labour and Welfare, as well as in preparing materials for submission and approval and preparing responses to inquiries from authorities. We can provide regulatory-related recommendations on pharmaceuticals and diverse topics including biologics, regenerative medicines (cell-based products and gene therapy medicinal products), and regulatory processes regarding medical devices, non-clinical studies, quality testing, and clinical studies.
Our consultants have specialist knowledge and a wealth of experience in their respective fields, enabling them to provide high-quality consulting services on diverse issues.
CMIC Medical Writing (MW) can provide a service for all CTD parts within CMIC Co., Ltd in collaboration with an affiliate company (CMIC Pharma Science). Optimal proposals are offered by medical writers fully experienced in extensive fields of various NDA categories.