 CMC REGULATORY
(Biologics Produced in USA/Europe)
Development and Registration in Japan
- Technical assessment of CMC document prior to IND in Japan
- CMC program roadmap and supply plan for Japan
- Gap-analysis of MCB, production process, formulation, spec & analytical method, and countermeasure for registration in Japan
- Communication and coordination with global CMC team
- Negotiation with PMDA (Pharmaceuticals and Medical Device Agency)
- IND filing, Coordination of clinical trial materials
- NDA filing and Registration
- CMC post-approval manufacturing change
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 CMC DEVELOPMENT AND PRODUCTION
cGMP Production & Formulation with Capable Outsourcing Party
- Project specific and customized CMC program planning
- CMOs selection and vendor management
- Hands-on project management, risk management, QC/QA support
- MCB, production process & scale-up, formulation development
- Spec, analytical method development & validation
- Production for non-clinical studies, cGMP production & drug disposition, clinical trial materials preparation
- Stability study program
- Pre-IND meeting, CMC package for IND filing, IND open
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