CMC Support

 Consultation and information services for CMC development, regulatory affairs, and quality management of pharmaceutical products

• Development of manufacturing processes for small molecules and biopharmaceuticals including antibodies (cell construction, culture, purification, and formulation)
• Specification setting and test method development
• Formulation, review, and project management of CMC development plans (process development, investigational drug manufacturing, data acquisition for regulatory submission, validation, etc.)
• CMC development strategy formulation and review (early-stage development, late-stage development, LCM of marketed products)
• Formulation of CMC regulatory strategies and support for consultation with authorities (consultation details and preparation of documents, etc.). In overseas, support in collaboration with local consultants
• Support for use of CMO/CDMO/CRO
• Support for technology transfer of manufacturing and analytical methods
• Support for formulation of quality management system (QMS), review and GMP management status review
• Implementation evaluation and implementation support

 Consultants for CMC development are few in Japan, and those with global experience up to the application for approval are extremely limited. Some of them use overseas consultants, but many of them may have difficulties due to the quality of their services, time difference with overseas countries, and language problems.
 In global development, it is necessary to manufacture investigational drugs, acquire data for regulatory applications, and set quality standards in compliance with the regulations of each country. PPBIZ provides CMC development, regulatory affairs, and quality assurance support services based on many years of experience to meet the needs of our clients. PPBIZ provides CMC development, regulatory affairs, and quality assurance support services tailored to your needs.