From Investigational Product to Commercial Manufacturing

CMIC Group is prepared to help guide your investigational product from development to technology transfer and into successful commercial manufacturing. We provide consistent and controlled procedures, as well as assurance of clear documentation of all processes and product knowledge. We provide a product that can be scaled up, with a well-developed process, identification of critical process parameters, critical quality attributes and other important parameters, robust validations, and commercial capability.

Our Edge in Technology Transfer

Efficient and solid technology transfer through a products’ lifecycle

  • Our team has the skills across regulatory, supply chain, quality management and commercial strategy to provide effective product transfers. We can streamline handoff of important information for commercial manufacture, using our stringent documentation and procedures.

Services

  • R&D validations, such as performance qualification
  • Installation qualification
  • Operational qualification
  • Technology transfer plans and reports
  • Engineering run, process qualification and process validation
  • Cleaning validation
  • QA check and approval of documentation
  • Manufacturing related documents, including drug product standards
  • Consultation with local authorities and PMDA

Development and Manufacturing

Formulation, Process and Analytical Development

Investigational Product Manufacturing

Packaging and Labeling

Release and Stability Testing

Commercial Supply

CMC Consulting Services

Consulting Services