The Catalent Cell Therapy Quality Control and Quality Assurance Groups (QC/QA) oversee the entire production process from the validation of equipment to the approval of the documents required to release the CGMP product. Our systems and procedures are developed and maintained to ensure CGMP compliance to applicable FDA and EMA regulatory requirements and standards.
Our quality systems are GMP-certified and are designed to meet the strict requirements of ATMP 1394/2007. Our Quality Assurance (QA) team provides directions throughout a customer project to ensure its efficient management and successful execution while keeping the highest levels of transparency, consistency, and reproducibility.
Our CGMP manufacturing services deliver excellence in quality, operations, customer satisfaction, and future vision for your therapeutic product. Catalent has the leading expertise and a global network to scale-up and scale-out allogeneic and autologous therapies, respectively. Our state-of-the-art CGMP facilities in Belgium and the USA are both FDA and EMA compliant, offering flexibility and confidence in manufacturing at a global scale.