Combining Strategy, Quality and Engineering to Delivery Modern Life Sciences Solutions.

Strategic Services

Regulatory Roadmap and Strategic Planning

QMS and GxP Systems Development

Owner Representation

Audits and Due Diligences

Engineering Services

Integrated Commissioning and Qualification

Process Engineering

Cleaning Validation

Process Validation

Air Flow Visualization

Decomissioning

Connecting People, Process and Strategy

Our Mission is to modernize Life Sciences Companies; we were founded on a principle to put people first, and are focused on the intersection of processes and strategy.

Critical Mass Consulting offers premier services to early stage organizations, and brings decades of Life Sciences Thought Leadership to our clients. Our curated team of experts can deliver on truly strategic intiaitves, to help accelerate the pathways from clinical stage to commercialization.

[Meet our Team]

We help develop regulatory roadmaps, develop Quality Systems, and provide expertise in Owner Representation for complex, multi-vendor projects such as Greenfield Facility Build Outs and Expansions

Breathing Life Sciences

At the heart of our Technical Service Offerings lies a commitment to addressing Engineering and Validation challenges. We are a modernized company with expertise in implementing Risk-Based, Integrated Commissioning and Qualification programs. Our team of Engineers possesses a comprehensive understanding of Electronic Validation Systems, specializing in providing support for both Single-Use Technology (SUT) and Stainless Steel facilities. We excel in processing system start-up, and ensuring these systems are qualified in a compliant and risk-based manner.

Our Clients Retain the Knowledge of Our Entire Company

Our Technical Services team of experts operates separately from our Strategy Team, yet both sectors of the organization are linked through robust internal processes that foster extensive knowledge sharing and cross-training. We firmly believe that maintaining a disciplined focus in both areas is essential for connecting people, processes, and strategies effectively.

Our Blog


Conceptual design

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Bayer New Facility + Therapy for Parkinson’s Disease

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Navigating the Biotech Frontier: Operational Planning & the “Commander's Intent”

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Get in touch with us today.