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About PA Pharma CMC Consulting

PA (Phase-Appropriate) Pharma CMC Consulting, LLC is a technical consulting firm based in Boston, Massachusetts. As a privately held limited liability company, we focus exclusively on CMC (Chemistry, Manufacturing, and Controls) support for pharmaceutical and biotech industries — from preclinical stages through commercialization. Our mission is to help clients successfully develop and obtain regulatory approval for their drug products, while maintaining strict compliance with GxP standards. We provide expert oversight of DS and DP development and manufacturing activities at external partners (CROs, CDMOs, CMOs), ensuring alignment with your overall project timelines. Our consulting services include: • Analytical Development & Quality Control • Excursion Management (OOS/OOT investigations, root-cause analysis, CAPA implementation) • Document Review and Approval • Analytical procedure DoE, optimization, qualification/validation • mutagenic/genotoxic impurity monitoring • ICH GMP/non-GMP Stability Studies • Process Characterization and Risk Assessment • Specification Justification Reports • Structural Characterization & Potency Assays • Qualification of Process Materials (starting materials, impurities, drug substances, etc.) • Spiking and Purge Studies • CTD Module 3 Authoring and Review • RTQ for regulatory queries Client satisfaction is our top priority and the driving force behind our work. We are committed to delivering affordable, flexible, and professional consulting services tailored to the unique needs of each client. Company managed by Sean Guo PhD — www.linkedin.com/in/xun-guo-a5097484; sean.guo@papharmacmcconsult.com

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