Klassen Consulting, LLC specializes in providing practical advice and guidance on Chemistry, Manufacturing and Controls (CMC) and Regulatory Compliance for pharmaceutical, biotechnological, and biological sterile injectable drug products. They offer assistance in preparing Active Pharmaceutical Ingredients and Drug Product Submissions to the U.S. FDA, focusing on mitigating submission failures and rejections. Additionally, Klassen Consulting helps companies with remediation and prevention of Regulatory Compliance issues to avoid regulatory actions such as warning letters and consent decrees. Their services include IND, NDA, BLA, DMF applications, supplements, amendments, and annual reports, along with project and crisis management experience in regulatory action remediation.