キューズコンサルティング Company Profile

Business Activities

1. Consultant Services Support for the development of pharmaceutical regulatory strategies Work analysis for the efficiency of safety management operations and proposals for business improvements Advice and support for responding to various inquiries and consultations with authorities Assistance in obtaining and renewing manufacturing and sales licenses Creation of various SOP drafts Support for venture companies, exit strategies, and early POC acquisition Portfolio management and project management Management of outsourcing partners such as CROs 2. Safety Management Services Contracted safety management services for pharmaceuticals and medical devices Collection and review of safety management information (such as adverse effects) and preparation of action proposals Drafting of revisions to package inserts Safety evaluation proposals using our proprietary safety database (for clinical trials and post-marketing) Preparation of risk management plans (RMP), regular benefit-risk evaluation reports (PBRER), periodic safety update reports (DSUR), regular reports on unknown non-serious adverse events, and infectious disease reports 3. Quality Change Management Services Support for change management of specifications and testing methods Advice and support for responding to inquiries from authorities Maintenance of approval documents, primarily support for minor change notifications related to CMC and some change application approvals Support for GMP compliance inspections, regular GMP inspections, and obtaining certification for foreign manufacturing sites

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