Operational Excellence for Life Science Manufacturers



Lean Biologix is a unique service provider for regulated manufacturers. We leverage a combination of current technology and lean principles to deliver efficient and manageable solutions. Our close integration with your internal resources lets us fully understand your problems to provide sustainable process improvements that have a lasting impact.


Learn how we apply these principles to your next project.

Project Management

All Lean Biologix personnel are trained to effectively manage and execute projects through continuous communication and time management skills.

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We understand that compliance is critically important and believe that creating a simple, stress-free process is the key to maintaining control and eliminating deviations.


Lean Biologix has expertise in shipping qualification, CQV Testing, CSV using the GAMP 5 process.

Whitepaper: Evaluation of Shipping System Qualification Data


We qualify Biotech, Gene Therapy and Pharmaceutical manufacturers packaging and shipping systems within domestic and international supply chains.

Download the whitepaper to leverage our knowledge of regulatory requirements, industry standards, and best practices to support all aspects of shipping qualification. We have a standardized process for managing shipping qualification programs that has been proven successful with regulatory agencies and eliminates “re-inventing the wheel” when developing or qualifying additional assets within a client’s portfolio.  Read More


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