Newsletter | November 6, 2025

11.06.25 -- Still managing CMC activities manually? There's a better way.

Why Manual QbD Leads To Delays, Errors, And Ongoing Frustrations

Manual approaches to Quality by Design (QbD) are increasingly outpaced by the demands of modern drug development. Gain insight into how intelligent, digital frameworks are helping CMC teams improve quality, accelerate submissions, and meet rising regulatory expectations.

 

Combining Digital Platforms And QbD Principles

Learn about ICH Q8, Q9, Q10, Q11, and Q14, which emphasize principles related to pharmaceutical development within the QbD framework, analytical procedure development, and risk management. Further, explore how data and digitalization can enhance development.

 

CMC Development Bottlenecks: The True Impact Of Manual Processes

Manual workflows in Chemistry, Manufacturing, and Controls (CMC) development often lead to delays, data silos, and compliance challenges that can jeopardize regulatory readiness. Discover how digitization can eliminate bottlenecks, improve traceability, and accelerate timelines.

 

SOLUTIONS

The Digital Suite For Process Lifecycle Intelligence

Find out how you can streamline process development and verification with a digital suite that enhances efficiency, ensures compliance, and supports real-time monitoring across manufacturing environments.

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