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QuTEM AB Secures GMP Certificates and Manufacturing Permits for Enhanced TEM Services
QuTEM AB, a renowned provider of transmission electron microscopy (TEM) services, has announced the acquisition of Good Manufacturing Practice (GMP) Certificates and Manufacturing Permits for its laboratories. These were granted by the Swedish Medical Products Agency. This certification strengthens QuTEM’s ability to conduct essential quality control analyses for both human and veterinary medicinal products.
The new permits enable QuTEM to meet high regulatory standards necessary for pharmaceutical product release. The recognition by the Swedish Medical Products Agency highlights QuTEM's dedication to maintaining high-quality standards in drug development and quality control using advanced TEM technology. With facilities capable of handling micro- and nanoparticle analysis, QuTEM remains a key player in the pharmaceutical industry.
CEO Dr. Josefina Nilsson highlighted the company’s unique position in the market as a pioneer in GMP certified TEM services. With these certifications, QuTEM not only continues the legacy of its predecessor, Vironova BioAnalytics, but also adapts to evolving quality standards. She emphasized the value QuTEM offers to its clients through precise and reliable analytical services, essential for robust pharmaceutical development.
R. P.
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