Content Video
ValGenesis iCMC™: Science-Driven. Risk-Controlled. Designed for Robustness.
0:11 Scattered documents, manual errors, and siloed decisions slow down development and introduce unnecessary risk.
0:18 It’s time to ditch the old way of juggling spreadsheets and scattered documents with a structured, digital system purpose-built for CMC development.
0:27 ValGenesis iCMC applies QbD principles from the start—enabling teams to evaluate critical parameters and build robust, risk-based development strategies.
0:37 iCMC aligns development with product CQAs, streamlines risk assessment, and supports confident, science-based decision-making across process and analytical method development.
0:47 With structured workflows and built-in knowledge continuity, iCMC improves traceability, accelerates decision-making, and reduces manual effort across the development lifecycle.
0:59 ValGenesis iCMC—an intelligent foundation for faster, compliant, and data-driven CMC development.
Summary
Scattered documents, manual errors, and siloed decisions slow CMC development and add avoidable risk. ValGenesis iCMC replaces spreadsheets and ad‑hoc files with a structured digital system built for CMC.
Using QbD from the start, teams can assess critical parameters, align work to product CQAs, and follow consistent workflows with knowledge continuity. The result is better traceability, faster decisions, and less manual effort across development.
Key takeaways
• Moves CMC development out of spreadsheets and scattered documents into structured digital workflows.
• Applies QbD early to evaluate critical parameters and align development to product CQAs for science-based decisions.
• Improves traceability and knowledge continuity to reduce manual effort and speed decisions across the development lifecycle.
Who is this for
• CMC development leads and program managers
• Process development scientists
• Analytical method development scientists
• Formulation and development scientists
• Technology transfer leads and MSAT teams
• Quality risk management and QA professionals
• Regulatory CMC writers and submission teams
Relevant entities and links
• International Council for Harmonisation (ICH) – Q8(R2) Pharmaceutical Development (QbD guidance): https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf
• ICH – Q9 Quality Risk Management: https://www.ich.org/page/q9-quality-risk-management
• European Medicines Agency (EMA) – Quality by Design (QbD) guideline hub: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/quality-guidelines/quality-quality-design-qbd
• EMA – ICH Q8 (R2) Pharmaceutical development (scientific guideline page): https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development-scientific-guideline
