We help our clients operate efficiently and with confidence, meeting ambitious development timelines by anticipating regulatory expectations and avoiding common CMC pitfalls that can result in costly delays. Proactive collaboration and clear, consistent communication are central to our approach, allowing sponsors to navigate the inherent complexity and uncertainty of regulatory development.
CMC Regulatory Services is committed to expanding patient access to safe, effective, and high-quality medicines. We maintain a patient-centric perspective in all of our work, recognizing that patient wellbeing—and confidence in the safety, quality, and effectiveness of their therapies—is the ultimate measure of regulatory success. Our strong track record in anticipating FDA feedback reflects our depth of experience in interpreting guidances and understanding the submission content required to achieve regulatory milestones, from first-in-human studies through post-approval changes.
Who We Are
CMC Regulatory Services, LLC, has supported biopharmaceutical companies in developing successful regulatory submissions since 1998. We provide expertise across all aspects of CMC regulatory strategy, authorship, editing, and submission management, supporting programs from early development through the post-approval lifecycle.
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Paul Kleinman
FOUNDER & PRINCIPAL CONSULTANT
Paul Kleinman is a veteran in CMC regulatory biopharmaceutical submissions and is the CEO/founder of CMC Regulatory Services, LLC. After receiving his B.A in Genetics from U.C. Berkeley and his Masters degree in cell and molecular biology from San Francisco State University, he started his career at the pioneering Cetus Corporation, where his first job was writing the original operator’s manual for the Perkin-Elmer-Cetus DNA Thermal Cycler (PCR). He then went on to write the genetic engineering and manufacturing process sections for the approved Product License Application for Betaseron, one of the earliest recombinant DNA therapeutic proteins of the DNA revolution in the late eighties.
As a CMC regulatory consultant, he has worked with dozens of biotech companies writing regulatory submissions and helping figure out innovative solutions to keep product development on the best path to regulatory success. He has also created and taught courses in regulatory compliance and Module 3 submissions. His work with novel biopharmaceutical products has given him a keen appreciation of the scientific and regulatory work needed to bring new drug products to patients.
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Daniel Kleinman
MANAGING DIRECTOR OF SUBMISSION QUALITY
Dan Kleinman is a regulatory affairs professional with more than a decade of experience supporting CMC regulatory submissions for innovative biopharmaceutical products. He has worked extensively on the preparation, review, and quality control of Module 3 content for INDs, NDAs, BLAs, and Drug Master Files, contributing to submissions across a wide range of therapeutic modalities, including biologics, small molecules, and complex combination products. His work emphasizes regulatory precision, internal consistency, and alignment with FDA expectations throughout the submission lifecycle.
As Managing Director of Submission Quality at CMC Regulatory Services, Dan is responsible for ensuring that all regulatory deliverables meet rigorous technical, organizational, and compliance standards. He plays a central role in coordinating cross-functional input, managing document development workflows, and resolving complex CMC issues that arise during submission preparation and agency review. His approach combines detailed hands-on authorship with strategic oversight, allowing clients to move efficiently through development milestones while minimizing regulatory risk.
Prior to joining CMC Regulatory Services, Dan worked in education consulting, publishing, and legal support, experiences that continue to inform his clear, structured approach to regulatory writing and project management. He holds a B.A. from Brown University and is completing a Master of Science in Regulatory Affairs at San Diego State University. His work is driven by a commitment to helping clients translate complex science into clear, FDA-ready submissions that support timely regulatory success.