Our Services

Development Regulatory Affairs & Pharmaceutical Regulation

  • Formulating development regulatory strategies
  • Support for various consultations with authorities
  • Advising on and supporting the creation of responses to inquiries
  • Assistance with obtaining and renewing manufacturing and marketing licenses

CMC Regulatory Affairs

  • Advising on CMC application strategies.
  • Preparation and review of application documents (quality section).
  • Support for change management in manufacturing processes, specifications, and test methods.
  • Advising on and supporting the creation of responses to inquiries and face-to-face meetings.
  • Maintenance of approvals, particularly support for minor change notifications and partial change approval applications in CMC.
  • Assistance with GMP conformity assessments, routine GMP conformity inspections, and obtaining and renewing certifications for foreign manufacturers.


  • Implementation of safety management information collection and review (e.g., side effects), and creation of action plans.
  • Consulting on cost-effective database (DB) implementation.
  • Creation of revision proposals for package inserts.
  • Utilization of our safety database for safety evaluation proposals (clinical trials and post-marketing).
  • Creation of Risk Management Plans (RMP), periodic benefit-risk evaluation reports (PBRER), Development Safety Update Reports (DSUR), periodic reports on non-serious unknown adverse reactions, periodic infectious disease reports, etc.
  • Formulation and monitoring of Post-Marketing Surveillance (PMS) plans, including statistics, data management, and re-examination responses.

Post-Marketing Surveillance

  • Full outsourcing of PMS-related tasks.
  • Creation of Risk Management Plans (RMP).
  • Development of Standard Operating Procedures (SOPs).
  • Preparation of implementation plans.
  • Facility contract services and monitoring.
  • Data management.
  • Statistical analysis.
  • Medical writing.
  • Re-examination tasks.
  • Contracting and monitoring through PharmaLink®*.
  • PhaemaLink® refers to the post-marketing surveillance system for rare diseases and rare cancers that CUES Consulting is newly promoting. It is a reliable yet cost-effective approach to conducting studies after the release of pharmaceutical products.

Professional Services

  • New drug pricing strategy and price negotiations.
  • Clinical trial domestic manager (ICCC).
  • Creation of various SOPs.
  • Support for obtaining business licenses.
  • Conducting and providing feedback on mock inspections at the time of business license renewal, covering both quality and safety aspects.
  • Support for operational diagnostics of the reliability assurance department, considering organizational design, roles and responsibilities, staffing levels, and business processes.

Inquiries & Consultations Are Free.
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