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Projects

Lean Biologix works with biotech industry leaders ensuring they meet strict regulatory filing deadlines and compliance initiatives in supply chain and IT operations.

Fast Tracked Gene Therapy Shipping Qualification for BLA

Fast Tracked Gene Therapy Shipping Qualification for BLA

A global biotechnology company working toward regulatory approval of a gene therapy treatment was required to perform shipping validation to support review and approval in the US market. As the primary indication was targeted for fatal neuromuscular genetic disease...

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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