Klassen Consulting

Klassen Consulting LLC specializes in providing practical and realistic guidance in Chemistry Manufacturing and Controls (CMC) and Regulatory Compliance, particularly for pharmaceutical and biotechnological companies involved in producing sterile injectable drug products. With a focus on navigating the complexities of U.S. FDA regulations, they offer expertise in enhancing submission quality to mitigate the risks of failures and delays.

The firm also addresses the critical need for compliance among suppliers, manufacturers, and distributors to prevent costly long-term repercussions, including fines and potential legal consequences. Through their services in remediation, prevention, and quality assurance, Klassen Consulting aims to protect clients from regulatory pitfalls while ensuring sustainable operational success.

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