Non-clinical Development

Non-clinical Development

CoreMed evaluates available nonclinical data (gap analysis), identifies necessary nonclinical data to start clinical trials and establish most appropriate nonclinical data package for marketing approval, which leads to successful marketing approval. CoreMed advises on nonclinical development and data package based on the most up-to-date information on regulatory requirements in Japan as well as in US and EU. CoreMed helps clients develop nonclinical study protocols and identify appropriate contract lab, if additional nonclinical studies are necessary.

CoreMed provides the following services

  • Nonclinical gap analysis
  • Solutions to the gaps
  • Nonclinical development strategy
  • Advice on minimum nonclinical data requirements for CTNs/INDs and NDA submission
  • Nonclinical study protocols
  • Selection of contract research laboratories including monitor and audit
  • Consultation meetings with the PMDA
  • GLP compliance inspection
  • Regulatory submission dossier (CTD/eCTD, CTN, IB, ODD)
  • Responses to the inquiries from the authorities
  • R&D and Regulatory Due Diligence
  • Feasibility study

Pickup

Business Alliances

  • Japan | eCTD | Digital Media Systems, Co. Ltd.
  • FDA | GxP Compliance | Polaris Compliance Consultants, Inc.
  • FDA |Global Regulatory Consulting | B&H Consulting Services, Inc.
  • EU | Global Regulatory Consulting | Dr. Regenolod GmbH
  • SFL Regulatory Affairs & Scientific Communication Ltd.
  • Headquarters
    Tsunenari Bldg., 2-1-21, Kitahama, Chuo-ku, Osaka 541-0041, Japan
    (TEL)+81-(0)6-6221-1352
    (FAX) +81-(0)6-6221-1357

    map
  • Tokyo office
    KN Nihonbashi Bldg., 4-8-17, Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023, Japan
    (TEL) +81-(0)3-5205-2757
    (FAX) +81-(0)3-5205-2758

    map
PageTop