AZ Biopharm is a GLP certified testing facility for the following test categories:
- Physicochemical properties and quantitative analysis (I)
- Analytical tests on biological materials (VIII)
Ceritficate of GMP-Compliance for a Pharmaceutical Laboratory Accounting to § 13 (1) and § 72 of the German Drug Law
permitted activities
quality control
Chemical / Physical
The permit includes the testing of drugs and medicines.
The testing facility operates in the following business areas:
Our services include the following:
Preparation of complete documentation required for market authorisation, as well as scientific studies in line with quality standards.
Some 150 validated methods for the quantitative analysis of active agents in biological matrices, such as blood plasma and urine tests, from clinical tests or animal tissue; analysis of residues with the aim of determining withdrawal periods for veterinary pharmaceutical products.
Both the development of our methods and our validations comply with Guidance for Industry: Bioanalytical method validation 2001.
Highly efficient HPLC, LC-MS/MS and GC-MS systems.
Have a look at our equipment.