Scope of Services - 5 Areas of Consultation
Drug Discovery Research: Consultation for R&D of Biopharmaceuticals (Antibody Drugs)
- Assess target product profiles through efficacy testing, feasibility studies, etc.
- Evaluate biotechnology including thorough research on competing products
- Develop R&D strategy including road map preparation
- Assess biotech methods, evaluate levels of technological, and resolve issues
- Design strategic development plan, develop specific schemes, screen drug candidates
CMC Development: Consultation for CMC of Low-molecular Compound, Biopharmaceuticals and Regenerative Medicine
- Review protocols and reports including CTD
- Establish manufacturing control system and selection of appropriate CMO
- Implement quality control system, laboratory management
- Implement quality assurance system including GMP compliance inspection of manufacturing and self-inspection
- Support PMDA consultation meetings e.g. Answering inquiries / Accommodating site inspection
Regenerative Medicine: Consultation to enhance value of target drugs for regulatory approval
- Evaluate profitability
- Establish manufacturing/quality control system, GCTP compliance, biological raw materials criteria, etc.
- Prepare pre-clinical/clinical trial packages, determine target disease
- Support PMDA consultation, development strategies, consultation document preparation, F2F meetings
- Manage R&D site
Clinical Development: Consultation for Development of Immunological Diseases
- Ensure risk management plans
- Prepare and review Japanese IND/NDA for meetings/negotiations with PMDA
- Assist outsourcing schemes, manage both local & foreign CROs
Business Development: Consultation for Licensing-In, Licensing-Out to Local/Foreign Pharma
- Assess products for out-licensing
- Assess in-licensed products
- Contact and arrange meetings with KOL
