service
Development & Post-Marketing Regulatory Affairs
We provide comprehensive regulatory support covering development strategy, PMDA consultation support, application document preparation support, responses to PMDA inquiries, orphan drug designation applications, MAH licensing and renewal, and regulatory audits and inspections.
Our Services
- 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
- Support for obtaining pharmaceutical marketing authorization holder (MAH) licenses and manufacturing licenses from prefectural authorities
- Mock inspections and feedback in preparation for MAH license renewal
CMC Regulatory Affairs
We provide end-to-end CMC regulatory support, from CMC regulatory strategy during development through GMP compliance inspections, accreditation of foreign manufacturers, and post-approval quality change management.
Our Services
- Advisory on CMC regulatory strategy for submissions
- Preparation and review of submission dossiers (quality section)
- Support for change control related to manufacturing processes, specifications, and test methods
- Advice on responses to regulatory queries and support for meetings with authorities
- Maintenance of marketing authorizations, including support for minor variations (CMC) and partial change applications
- Support for GMP compliance inspections and periodic GMP inspections (including overseas on-site inspections), as well as foreign manufacturer accreditation and renewals
- CMC regulatory support across various modalities, including biologics and antibody therapeutics
Pharmacovigilance
We assess product safety profiles and propose appropriate pharmacovigilance and risk-minimization measures. We also support case assessment, safety database operations, and global PV audits based on international regulatory requirements.
Our Services
- Collection and evaluation of safety information (e.g., adverse events) and development of risk mitigation actions
- Implementation and operation of cost-efficient safety management systems using a safety database, enabling centralized data management and reduced manual workload (clinical and post-marketing)
- Preparation of package insert revision proposals
- Preparation of RMPs, PBRERs, DSURs, periodic reports for non-serious unknown adverse events, and infectious disease reports
- Support for re-examination processes and preparation for on-site and document-based inspections
- Conduct of global audits based on international regulations (including EU GVP) and support for building internal audit systems, including audits of overseas partners and licensees
Professional Services
We provide a broad range of professional services, including new drug pricing strategy, SOP development, promotional material review, and global expansion support.
For companies aiming for international expansion, we offer support in development strategy planning and regulatory approval through SCENDEA, our partner based in the UK.
For companies aiming for international expansion, we offer support in development strategy planning and regulatory approval through SCENDEA, our partner based in the UK.
Our Services
- New drug pricing strategy and price negotiations
- Development of SOPs for GQP, GMP, GVP, etc.
- Review of promotional materials for compliance with applicable laws, regulations, and guidelines
- Operational assessment of reliability assurance functions, including organizational design, roles and responsibilities, staffing, and business processes
- Support for global development strategy and regulatory approval
- PV global audits based on international regulations, including EU GVP, and support for establishing audit systems
Professional Recruitment & Staffing
We support the recruitment and effective utilization of specialized professionals in regulatory affairs, CMC, and safety management.
