Tel:+81-3-5843-8480 Tokyo office
Tel:+81-78-219-4626 Kobe office
Services: Biopharmaceutical CMC Development Consulting Service

CMC experts of Pharma Training, Inc. experienced in CMC works of biological products and registration in senior level positions, support the efficient and successful registration & CMC-related tasks of:
  • Technical Assessment
  • Up- & Down-stream Processes
  • Formulation
  • Spec & Analyses
  • cGMP
  • IND & NDA
(Biologics Produced in USA/Europe)

Development and Registration in Japan

  1. Technical assessment of CMC document prior to IND in Japan

  2. CMC program roadmap and supply plan for Japan

  3. Gap-analysis of MCB, production process, formulation, spec & analytical method, and countermeasure for registration in Japan

  4. Communication and coordination with global CMC team

  5. Negotiation with PMDA (Pharmaceuticals and Medical Device Agency)

  6. IND filing, Coordination of clinical trial materials

  7. NDA filing and Registration

  8. CMC post-approval manufacturing change

cGMP Production & Formulation with Capable Outsourcing Party

  1. Project specific and customized CMC program planning

  2. CMOs selection and vendor management

  3. Hands-on project management, risk management, QC/QA support

  4. MCB, production process & scale-up, formulation development

  5. Spec, analytical method development & validation

  6. Production for non-clinical studies, cGMP production & drug disposition, clinical trial materials preparation

  7. Stability study program

  8. Pre-IND meeting, CMC package for IND filing, IND open