Based in San Diego, CA in the heart of San Diego’s life science, Research and Development and Pharmaceutical Manufacturing community. Our group is comprised of pharmaceutical industry experts who have collaborated and have been mentored by current and former US FDA leaders, who have successfully remediate consent decrees, warning letters and 483 citations. As life science professionals, who have worked with countries such as United States, Canada, Brazil, India, and throughout Europe, the question was pose, quality standards should be developed to compete globally as well.
Our group understands the challenges pose of the regulated industry, understands the need to compete and be cost conscious, but wants pharmaceutical leaders to understand that in order to have a competitive advantage, ensuring financial growth and viability, “compliance and quality” is the key. A group of experience industry professionals with strong ties and proven compliance histories were assembled, and thus formed Quality Compliance Good Manufacturing Practices Group. We will work to understand our client’s needs and
processes, and together create pragmatic cost effective compliant solution.