Enter the age of intelligent CMC development

What’s in it

This brochure outlines how Valgenesis iCMC™ supports science-based process design using QbD principles early in process and analytical development, targeted risk assessment across CQAs, CMAs, and CPPs, and structured justification of robust control strategies for process monitoring and product quality across stages.

It also shows how an integrated digital system can replace spreadsheets with knowledge-driven workflows to reduce manual errors and scattered documentation, while helping teams design robust processes that consistently meet product CQAs, improve efficiency during scale-up, and support technology transfers.

Who this is for

• CMC development leaders responsible for end-to-end process and analytical development strategy
• Process development scientists building QbD frameworks and defining CQAs, CMAs, and CPPs
• Analytical development leaders managing analytical method development and control strategies
• MSAT and tech transfer leads preparing scale-up and technology transfer packages
• Quality and QA leaders overseeing risk-based development documentation and inspection readiness
• CMC regulatory affairs professionals coordinating CMC content expectations and change readiness
• Digital transformation and IT leaders replacing spreadsheet-based workflows with governed systems

What it helps with

• Replaces spreadsheet-based QbD work with structured, workflow-driven execution
• Standardizes how teams assess CQAs, CMAs, and CPPs to reduce gaps and rework
• Helps build and justify control strategies in a consistent, traceable way
• Reduces manual errors by centralizing knowledge and documentation in one system
• Improves efficiency during scale-up and technology transfer by keeping development work organized and reusable