Connecting people, process, and strategy

Critical Mass Consulting partners with life sciences companies to accelerate their path from clinical development to commercialization. Founded on a people-first philosophy, we integrate strategy, process, and engineering to deliver practical solutions for complex challenges.

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Our Capabilities

We guide life sciences organizations through regulatory and operational challenges with a combined focus on strategy and engineering—so you can move forward knowing your systems, processes, and plans are inspection-ready.


Strategy Services

Regulatory Roadmapping & Strategic Planning

QMS and GxP Systems Development

Audits & Due Diligence

Owner Representation


Engineering Services

Cleaning & Process Validation

Airflow Visualization

Integrated Commissioning & Qualification

Process Engineering


Industry Insights