GMP-certified contract laboratory for microbiology, analytics, molecular biology/bioanalytics. At BioChem you receive high-quality laboratory services and scientific expertise from a single source in the areas of - MICROBIOLOGY - physico-chemical ANALYTICS - MOLECULAR BIOLOGY/Bioanalytics Our range of services covers the entire pharmaceutical-chemical contract analysis in a GMP-regulated environment, regardless of which phase of the life cycle your product is in: - Quality control and pharmaceutical development: - Analyses of raw materials, intermediate and finished products in any dosage form - Method development, transfer and validation - Determination of identity, content, purity, residues - Purification validation - Release and stability testing: - EU re-analysis - Storage according to ICH guidelines - GMP/GLP-compliant documentation: - Test specifications, plans, reports Founded in 1973, BioChem Labor für biologische und chemische Analytik GmbH is one of the leading analytical contract laboratories in German-speaking countries. We employ around 100 well-trained experts at our site in Karlsruhe, Germany. Our employees are qualified in handling highly potent and toxic substances such as e.g. narcotics (BTMs), cytostatic substances, hormones, antibiotics and CMR substances. Our global customers from the pharmaceutical, chemical, medical, diagnostic and cosmetic industries know us as a flexible and quality-assured full-service provider with a broad range of services geared towards analytical issues in GMP- and GLP-regulated as well as FDA-compliant environments. In regular inspections by the authorities and customer audits, we constantly prove compliance with all necessary GMP and GLP specifications. We carry out your analyses in accordance with the current guidelines (e.g. Ph. Eur., USP, JP, BP, HAB, DAB, AMG, MPG, ...).