Accreditation and Licenses

  • Laboratory accredited by the DAkkS German Accreditation Body (DAkkS Deutsche Akkreditierungsstelle GmbH) in accordance with DIN EN ISO/IEC 17025:2005 Reg.-No.: D-PL-18472-01-00 (PDF-Download)

  • GMP: Approved test laboratory for contract analysis of medicinal products in accordance with § 14 Sect. 4 of the German Pharmaceuticals Act (AMG - Arzneimittelgesetz) (PDF-Download)

  • GLP accreditation by the Federal authority in Mainz (PDF-Download)

  • Accredited for the analysis of narcotic drugs in accordance with § 3 of the German Narcotics Law (Betäubungsmittelgesetz, BtMG)

  • Permission to work with pathogens in accordance with § 44 IfSG (law on protection against infection)

Country-specific approvals

  • officially recognized laboratory in accordance with § 15 Abs. 4 TrinkwV 2001

Continuous Quality Assurance

  • Participation in national and international inter-laboratory proficiency tests, e.g. characterization studies of EDQM (European Directorate for the Quality of Medicines & HealthCare), Strasbourg

  • Continuing education of our employees via seminars and training courses (e.g. CONCEPT GmbH, Heidelberg)

  • Regular audits by our customers and surveillance authorities