To ensure the long-term fulfillment of specific customer requirements for our products and services, our quality management system has complied with each guideline and specification of the internationally accepted standard DIN EN ISO 9001 since 1999.
We follow a constant process of improvement and are audited regularly and successfully by customers.
Our laboratory performance, especially for industrial customers, strictly follows many GMP standards. Our quality system is based on the following principles:
- Animals and materials from certified suppliers
- Quality according to US standards
- Batch control system
- Cell line history and cell banking
- Assay validation according to the ICH guidelines
- Validated analytical procedures
- Documentation according to the regulatory guidelines
- Well-experienced and regularly trained personnel
- Internal audits routinely and audits by customers
Animal keeping and corresponding work is performed according to the following animal welfare regulations:
- German guidelines according to Animal Welfare Act of 12. August 2013 (BGBI.I, No. 36)
- European Union guidelines 2010/63/EC of 22.09.2010 and according to the European Agreement of 18.03.1986 for protection of animal trials and other for scientific purposes used vertebrates of 15.11.2007 (BGBI. II No. 37)
- NIH/OLAW Animal Welfare Assurance #A5755-01