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- ...1223/2009) and applicable international standards. Maintain and evolve our Quality Management System (QMS), including ISO 13485 and GMP-related practices. Manage product registration, labeling compliance, claims substantiation, and post-market surveillance....
- ...based production platform through the BRX program, covering process development, assay development, lab and facility construction, and GMP readiness. Cellcolabs is based on 20 years of research from Karolinska Institutet and is approved for GMP production of ATMPs by...
- ...automation and information solutions as well as services for this sector. Eltronic services are tailored to the highly complex and GMP regulated life science industry. They support the entire manufacturing lifecycle from setting direction, realizing the benefits of...