Oakland, California, United States
Hello, I’m Paul Kleinman, founder of CMC Regulatory Services, LLC. I work hands-on with biopharmaceutical companies to develop strategy and author CMC submissions for biologics, new molecular entities, and combination products. My focus is on converting complex manufacturing and analytical data into clear, submission-ready Module 3 content aligned with FDA expectations. This includes defining control strategies, establishing development continuity through critical quality attributes, and structuring information to support efficient regulatory review. CMC Regulatory Services supports INDs, BLAs, NDAs, IMPDs, and global applications. Engagements typically involve close collaboration with subject matter experts and senior leadership to align regulatory strategy with product and corporate objectives. Work spans solution-oriented analysis, project management, and direct authorship/editing of submission-ready documents. Current work emphasizes helping companies navigate evolving FDA expectations by applying a practical, product-specific regulatory science approach. The goal is straightforward: well written, coherent CMC submissions that facilitate review and reduce downstream questions—getting it right the first time
CMC regulatory consulting for biopharmaceutical industry, Pre-IND through Post Approval; Interim Manager and Director roles
Strategic regulatory development and authoring CMC submission for successful IND, pre-NDA regulatory development for process and release test changes.
As Interim Director, CMC Regulatory Affairs, I worked on BLA post-approval mAb supplements, contributing to both regulatory strategy and document preparation. I also co-headed two submission teams, helped identify key FDA concerns, and worked closely with subject matter experts in document preparation.
At Gritstone Bio, I was contracted as a full-time CMC regulatory consultant responsible for writing and editing analytical sections of IND Module 3 and technical reports for mRNA vaccine INDs. I also reviewed Module 3 documents for information gaps.
I was contracted to work full-time for Juno Therapeutics as the Lead CMC Technical Regulatory Writer for one of the first CAR T-cell therapies approved by FDA. In consultation with subject matter experts, I authored and edited technical reports and corresponding BLA CMC sections for process, analytical, and manufacturing development for a pioneer CAR T-cell therapy. I also acted as project manager for technical writing projects and as a review team member for BLA sections. I ensured submission documents met FDA regulatory expectations while providing correct and consistent messaging. I also provided post-approval submission development for this CAR T cell therapy.