COREMED

CoreMed offers comprehensive support for all development and regulatory tasks, strategy, PMDA consultation, regulatory submission strategies including CMC, non-clinical, and clinical, and the preparation of regulatory submission documents (CTD M1-M5/eCTD). We handle various regulatory tasks associated with submissions and respond to inquiries through to approval. We also manage changes post-application and approval. All staff members at CoreMed are extraordinarily skilled, talented, creative, and experienced and grapple with projects toward a goal which is regulatory approval under Supreme Quality. Our people at CoreMed are passionately supporting pharmaceutical and biopharmaceutical companies bring products to launch by designing development strategies, nonclinical and clinical strategies for pharmaceuticals and biopharmaceuticals including regenerative medicines... CoreMed, a strategic regulatory and drug development consulting firm, was established in Osaka, Japan in March 1998...

Also known as: CoreMed Corporation

Primary location: Osaka Japan