Communication with regulatory authorities is essential in drug development and is a crucial step in determining the overall direction of the project. CoreMed establishes strategies and tactics for successful consultation meetings with the PMDA. Our goal is to ensure successful development and marketing approval in Japan. Our coverage extends beyond clinical to include CMC and nonclinical consultation meetings.

We evaluate available data and prepare briefing documents for consultation meetings. Additionally, we advise clients on what should be prepared and what should be discussed with the PMDA.
Acting on behalf of our clients, we organize PMDA meetings and liaise with the PMDA, including responding to inquiries.
In addition, we support consultations with the Ministry of Health, Labour and Welfare (MHLW) for orphan drug designation applications and SAKIGAKE (Innovative/pioneer drug) designation consultations.