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Pharmaceutical GxP Compliance Auditing Experts
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QbD Auditing, Inc. was founded by two seasoned experts in product development and commercialization. Our expertise encompasses biotech, pharmaceutical and medical device product development with special expertise in combination products. One of our objectives in forming this company, was to assist those organizations, especially start-ups and product development companies whose true focused objective is not to commercialize their products but to find a suitable partner to further develop and commercialize their intellectual property. From our experience in performing due diligence audits for major pharmaceutical companies has shown that in many cases a development company cannot realize the full potential of value of their IP due to their short-comings in their Quality System and as such the partner company has to repeat some of the work in order to yield data that is acceptable for a regulatory filing. We at QbD Auditing can assist with this by assisting the development organization with a Quality System that is specific for a research and development organization, which provides the controls in place without encumbering the creativity required by the development scientists. We know the difference between a Research & Development Quality System from that required for a commercial manufacturing facility. So we can ensure that the developing organization will retain their full “curb value” at the time of sale or purchase of their IP by the suitor company.
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