GMP certificates

We are proud to announce that QuTEM received GMP Certificates and Manufacturing Permits from the Swedish Medical Products Agency (Läkemedelsverket)  

QuTEM is thereby authorized to perform critical quality control analysis essential for the release of medicines to the market. The GMP Certificates and Manufacturing Permits cover medicinal and investigational medicinal products for both human and veterinary use.

GMP regulations are formal standards established by regulatory bodies worldwide to ensure the quality, safety, and efficacy of pharmaceutical products. Manufacturing Permits for Independent Quality Control Laboratories are granted by the Swedish regulatory authority since January 2024 to laboratories that conduct tests directly impacting the release of medicines. The GMP certificates and manufacturing permits are a testament to QuTEM's commitment to biopharma drug development and quality control through cutting-edge electron microscopy technology. 

As quoted on the GMP certificates by the Swedish Medical Products Agency, QuTEM enables: "Quality control of micro- and nanoparticles through transmission electron microscopy (TEM) with the techniques of staining (negative stain) and freezing (cryogenic) and with semi-automatic particle detection and analysis using software". The endorsement from regulatory authorities underscores QuTEM's position as a trusted partner in the pharmaceutical industry, equipped to meet stringent regulatory requirements.

Dr. Josefina Nilsson, CEO of QuTEM, expressed enthusiasm about the achievement, stating, "QuTEM's predecessor, Vironova BioAnalytics, made history as the world's first and only GMP certified electron microscopy laboratory in 2020. Since then, we have been providing GMP level TEM services. To this moment, we proudly maintain our position as the only provider of electron microscopy services holding a GMP certificate. Our clients are consistently impressed by our advanced laboratory, top-tier experts, and high service standards. They benefit through the preparation of accurate and reproducible image datasets, the generation of reliable quantitative data, and the robust conclusions from the analysis. Acquiring the GMP certificates and manufacturing permits signifies not only a seamless transition in business and quality assurance from Vironova BioAnalytics to QuTEM, but also showcases our adaptability in maintaining quality standards amidst evolving regulatory requirements."