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Non-clinical Development
CoreMed evaluates available nonclinical data (gap analysis), identifies necessary nonclinical data to start clinical trials, and establishes the most appropriate nonclinical data package for marketing approval. CoreMed advises on nonclinical development and data package based on the most up-to-date information and regulatory requirements in Japan as well as in the US and EU. CoreMed helps clients develop nonclinical study protocols and identify appropriate contract labs, if additional nonclinical studies are necessary.
CoreMed's non-clinical team helps clients
- ・Nonclinical gap analysis
- ・Nonclinical development strategy
- ・Advice on minimum nonclinical data requirements for CTNs/INDs and NDA submission
- ・Consultation meetings with the PMDA
- ・Documents preparation for GLP compliance inspection
- ・Documents preparation for Reliability compliance inspection
- ・Regulatory submission dossier (CTD/eCTD, Clinical Trial Notification (CTN), IB, ODD)
- ・Responses to the inquiries from the authorities
- ・R&D and Regulatory Due Diligence
- ・Selection of contract research laboratories including monitor and audit
- ・Nonclinical study protocols
- ・Evaluation and writing of study reports
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