Our Services

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.

Pharmacovigilance

• 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.
• Support for development strategy planning and regulatory approval in international markets.