Analytisches Zentrum Biopharm GmbH (EN)

We offer:

• method development and validation for stability testing, quantitative analysis and chemical purity testing of finished pharmaceutical products as well as active agents and additives
• approval-related testing under section 67 of the German Pharmaceuticals Act (AMG)
• stability testing in line with ICH guidelines, as well as storage of the test samples (including narcotic substances) in relevant conditions in qualified and secured climatic chambers with documentation of storage conditions
• testing following specifications of pharmacopoeias, testing specifications of the client, or individually tailored testing specifications
• testing of solid oral dosage forms, solutions and suppositories with regard to their physical properties, content, chemical purity and release
• authorisation for the handling of narcotic substances