compliance testing

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...

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