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
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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.
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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.
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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.
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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.