“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.”

Development of GXP (GLP, GMP, GCP) Quality systems consistent with FDA, EUDRA & ICH Guidelines. Provide QA development services to stage clinical trial material for EU QP release.

Participate with development of required process, testing and vendor audit for biologics, AAV Gene Therapy and small molecule products from early clinical phase through commercialization.

Ensure products and product development are produced consistent with global GxP regulatory expectations. Key expertise with working with CMO operations.

To provide quality assurance GxP services to the Bio Pharmaceutical Industry that ensures a robust audit ready GxP compliant drug product package, ensuring survival of regulatory scrutiny and ultimate approval of product.

Honesty

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Without question when assessing product suitability for disposition and interacting with partners.

Integrity

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

Respect

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