A & C Global Partners Inc, 2222 Huntington Dr, Apt 2, Duarte, CA 91010, US

Klassen Consulting, LLC is a trusted consultancy firm based in Duarte, CA, specializing in providing practical and realistic advice on Chemistry, Manufacturing and Controls (CMC) and Regulatory Compliance for pharmaceutical, biotechnological, and biological sterile injectable drug products. With a deep understanding of the U.S. regulatory landscape, they offer guidance on crucial sections of investigational and license submissions to mitigate the risk of failures and rejections, as well as assistance in FDA meetings to achieve successful outcomes. Recognizing the importance of regulatory compliance, Klassen Consulting, LLC also helps companies in remediation and prevention, ensuring suppliers, manufacturers, and distributors adhere to the necessary standards. Their expertise in quality assurance, quality systems, regulatory affairs, and CMC enables them to identify compliance risks and provide effective solutions to avoid or mitigate potential regulatory actions, such as warning letters or consent decrees, which can have severe financial and reputational consequences.Generated from the website

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