13.02.02 European "Medical Device Directive" 93/42 conformity assessment services
European "Medical Device Directive" 93/42 conformity assessment services
13.02 Testing, certification, quality assurance
13.02.03 Testing services
Eurofins BioPharma Product Testing Munich GmbH With more than 30 years of experience and thousands of GMP/GLP studies per year Eurofins BioPharma Product Testing Munich GmbH (formerly BSL Bioservice Scientific Laboratories GmbH) supports its clients especially in the fields of bioassays, microbiology, in vitro toxicology, pharmacology, and biocompatibility. Immunoanalytical and bioanalytical studies are offered as support of non-clinical and clinical programs. Eurofins BioPharma Product Testing covers the whole range from standardized test to special requirements and tailor-made studies. In addition to the pharmaceutical industry, Eurofins BioPharma Product Testing Munich serves customers in the medical device, agrochemical and chemical industries. Eurofins BioPharma Product Testing Munich has been certified in accordance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) and has been accredited with DIN EN ISO 17025 for the testing of medical devices. The company is listed by the World Health Organization (WHO) and has been audited successfully by the FDA.
Services for Medical Devices • Biocompatibility Testing • Cytotoxicity Tests • Sensitization Studies • Irritation Studies • Hemocompatibility Testing • Microbiological Testing • Implantation Studies (in collaboration with partner laboratory)
for Pharmaceuticals, Biologics & ATMPs • Process and Product Related Impurities • Bioassays • Method Development & Validation • Stability & Release Testing • Sterile & Non-Sterile Product Testing • Leachables & Extractables Testing • Immunoanalytical Studies • Bioanalytical Studies • in vitro Toxicology Studies • Pharmacology Studies
for (Agro)chemicals, Cosmetics & Food Additives • Irritation Studies • Sensitization Studies • Local Tolerance Studies (in collaboration with partner laboratory) • Genetic Toxicology