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CMC Support

B2S Life Sciences® specializes in CMC Statistical Support of biotherapeutics for those in the pharmaceutical industry.

With our relationship-driven focus from each of our partners in the Pre-Analytical, Analytical, and Post-Analytical phases of development, B2S Life Sciences® can assist in the development and validation of cell-based potency assays, HCP assays, and analytical methods.

Our CMC Statistical Support also extends to process and formulation development, process and assay control strategy and monitoring, establishing specifications and acceptance criteria, method and process transfer and worldwide regulatory submissions.