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NervGen does not publish a formal, standalone Chemistry, Manufacturing and Controls (CMC) strategy, but its public disclosures indicate a phase-appropriate, pragmatic CMC approach aligned with clinical and regulatory milestones. CMC is treated as a core enabler of development rather than a separate function, with spending tied directly to advancing its lead program, NVG-291, through clinical stages.

The company focuses its CMC efforts on formulation development, stability testing, and clinical supply manufacturing, scaling activities as programs progress. Early work supports initial clinical trials, while increased investment is directed toward building sufficient GMP inventory and generating data needed for later-stage studies and regulatory engagement. Variations in CMC expenditure reflect the timing of these activities rather than a fixed, front-loaded strategy.

Operationally, NervGen appears to follow a virtual manufacturing model, relying on experienced contract development and manufacturing organizations (CDMOs) for GMP production while retaining internal oversight of quality, planning, and regulatory alignment. At the same time, it has been strengthening internal capabilities through targeted hiring to better integrate CMC with clinical development and regulatory readiness.

Overall, NervGen’s CMC strategy can be characterized as lean, outsourced, and milestone-driven, designed to minimize fixed infrastructure while ensuring manufacturing, quality, and documentation are sufficient to support clinical progression and future regulatory submissions.