CoreMed evaluates available data (gap analysis) and prepares regulatory submission dossier such as CTD/eCTD Module 1 through Module 5, Orphan Drug Designation, DMF and Clinical Trial Notification (CTN).

Translation of overseas documents into Japanese is not always appropriate for Japanese submission. CoreMed prepares the dossier in the appropriate Japanese language and Japanese writing style based on our extensive experience with approval applications.

CoreMed provides comprehensive solutions, called “Medical Writing / eCTD Compiling Collaboration Services” collaborating with Digital Media Systems Co., Ltd who is a Japanese eCTD leading company and has significant expertise in eCTD which complies with Japan specific eCTD requirements. CoreMed writes CTD and prepares eCTD simultaneously from the beginning and completes the NDA application dossier seamlessly.

Furthermore, through our collaboration with A2 Healthcare Corporation, who has significant expertise in eData submission (CDISC), CoreMed provides one-stop support for creating CDISC packages, advising on electronic data applications, proposing PMDA consultation strategies, writing briefing documents, accompanying consultations, and other various supports, ensuring a smooth approval application process.