CM
Regulatory Affairs Specialist
Charter Medical
Winston-Salem, North Carolina, US
Charter Medical designs and supplies customized single-use solutions for cell therapy manufacturing and biological fluid handling, manufactured in ISO 13485-certified cleanrooms in Winston-Salem, North Carolina.
Charter Medical designs and supplies customized single-use solutions for cell therapy manufacturing and biological fluid handling, serving biopharmaceutical innovators developing advanced therapies. The company's product portfolio spans single-use cell growth systems, frozen storage solutions for biological materials, and single-use systems for handling biological fluids in biomanufacturing processes. Its work also extends to blood transfusion technology and broader pharmaceutical and biotechnology manufacturing.
Headquartered in Winston-Salem, North Carolina, Charter Medical operates 16,000 square feet of ISO 13485-certified cleanroom space and draws on nearly 35 years of experience in the field. Technical work covers single-use bioprocessing, cleanroom manufacturing, and custom engineering design, with engineers working directly with customers to develop tailored solutions rather than off-the-shelf products.
The company describes its culture as mission-driven, collaborative, and oriented toward continuous improvement, with an emphasis on simplifying and standardizing biomanufacturing systems step-by-step as customer needs evolve. Charter Medical is part of the Solesis family of companies and integrates its research and development with sister companies Polyzen, Secant Group, and SanaVita Medical.