Pharmaceutical and Medical Device Consulting

We provide effective and timely regulatory affair strategies matched to our clients’ needs.

Leveraging our people’s abundant experience, we support the development of regulatory strategy plans, consultation meetings with PMDA, approval applications, communications with regulatory authorities, and post-approval/marketing regulatory affairs.

Our consulting services cover all types of generic drugs as well as new drugs including chemical compositions and biopharmaceuticals.

Product Development Stage

  • Assessment of Due Diligence
  • Assessment of preclinical/CMC data
  • Assessment of use of overseas clinical study data
  • Proposal of domestic/international clinical study plans
  • Advice on construction of clinical data packages
  • Support for regulatory consultations with PMDA
  • Support for Clinical Trial Notification, Application for INN/JAN, Designation as orphan drug
  • Assessment of new excipients

Product Submission Stage

  • Assistance for use of pre-assessment consultation with PMDA
  • Preparation of NDA submission and CTD
  • Support with PMDA communication (response to questions) after NDA submission
  • Assistance for CCDS-based preparation of Package Insert
  • Preparation of application materials for Foreign Manufacturer Accreditation and GMP
  • Compliance Inspection
  • Support with Compliance Inspection of document & GCP Onsite Inspection
  • Assistance for the revision of CTD for the Drug Committee

Post Approval Stage

  • Assessment of Review Report and CTD masking works
  • Preparation of Basic Plan and Protocol for Post-marketing Surveillance
  • Support with application for NHI drug price listing
  • Support with GxP and works of Regulatory Affairs after product launch
  • Proposal of life cycle management
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