Mission:  To provide quality assurance GxP services to the Bio Pharmaceutical / Gene Therapy Industries that ensures a robust audit ready GxP compliant drug product package.  Ensuring survival of regulatory scrutiny and ultimate approval of product.  Key expertise in GLP, GMP and GCP implementation and management.  
 
Values: 
HONESTY; Without question when assessing product suitability for disposition and interacting with partners.

INTEGRITY; Always making the best choice in the best interest of product/process ensuring safety of drug product.

RESPECT; For the knowledge of CMO partners, product owners, manufacturing operations and CMO quality systems.

SERVICES PROVIDED: 

Provide QA GxP services to ensure,  Development of GXP Quality systems consistent with FDA, EU, ICH, JP requirements.

Provide QA development services to stage development DP for clinical trials.

Assist with navigating international industry regulations.

Ensure products and product development are compliant and consistent with regulatory expectations.

Biotechnology

L. Reed Global QA, Inc.

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