客户案例 – MQMR SOLUTIONS Srl.

End-to-end qualification and validation of sterile manufacturing facilities to meet EU, FDA, and WHO GMP requirements.

GMP-compliant production of investigational medicinal products for multinational clinical trials, aligned with CTD/ICH standards.

Technology transfer, process validation, and regulatory readiness for Active Pharmaceutical Ingredient supply to global regulators.

Alignment of laboratory operations with international biosafety and containment standards, including OECD GLP and GMP integration.

Strategic support for EU MAA, FDA NDA, and other global marketing authorization pathways.

Regulatory, quality, and compliance solutions for cell and gene therapies, tissue-engineered products, and ATMP classification.

Cases