CMC Management and Readiness

Chemistry, Manufacturing, and Controls activities shape product quality, clinical supply, and submission readiness.

With experience across research, CDMO operations, and sponsor organizations, I help teams connect technical development with regulatory planning. I work alongside manufacturing, analytical, and quality specialists to identify dependencies, assess changes, and coordinate execution.

• Phase-appropriate CMC gap assessments.
• Technology transfer planning and coordination.
• CDMO and testing laboratory oversight.
• Manufacturing process, site, and scale-change assessments.
• Comparability strategy and evidence planning.
• Review of characterization, potency, specifications, and stability plans.
• Module 3 content planning and review.
• CMC timelines, responsibilities, and risk tracking.

A CMC readiness assessment, prioritized action plan, reviewed documentation, and coordinated milestones aligned with your development needs.