Paul Kleinman

WORK HISTORY

EDUCATION

ABOUT PAUL KLEINMAN

Hello, I\'m Paul Kleinman, founder and CEO at CMC Regulatory Services, LLC. I\'m a regulatory CMC professional with a hand on-approach to strategizing and writing CMC submissions for biologics, new molecular entities, and combination products. After graduating from UC Berkeley (B.A. Genetics) and SF State University (M.A. Cell and Molecular Biology), I jumped into regulatory and technical writing for INDs and Biologic License Applications for recombinant proteins and Mabs. I\'ve also written CMC submissions for protein kinases and other small molecules. This has been a great training ground for understanding what FDA is really looking for in CMC submissions and for grasping that each client brings its unique challenge of corporate strategy and product/regulatory history. CMC Regulatory Services is a biopharmaceutical regulatory consultancy focusing on the strategy and production of CMC regulatory submissions for cutting-edge-new biologics and drug therapies. We also prepare versions of Module 3 aligned for IMPDs and market applications. In all cases, we work closely with subject matter experts to ensure their work is properly represented to the Health Authority and work with Senior Managers to understand their views, share options and recommendations and make sure corporate expectations are met. Our work is hands- on all the way from solution-oriented analysis, to helping project-manage, draft and edit Module 3 submissions that are ready to publish.FDA\'s evolution in their CMC compliance expectations has kept us on our toes. Today, the key to providing high quality submissions is through experience and understanding of FDA’s regulatory science approach as they apply to the company\'s specific therapeutic product. This means presenting the risk management, and control strategy based on identification of critical quality attributes and manufacturing processes. The result is a streamlined regulatory review. We have found that the most efficient path to regulatory submission success is getting it right the first time.