We hold all required certificates to carry out work for the pharmaceutical industry. The implementation and compliance to current quality standards governed by the employees of the quality assurance department. In the field of pharmaceutical analysis, our laboratories are bound by the regulations of Current Good Manufacturing Practice (cGMP) of the EMA, FDA and ICH. Local authorities assess and confirm compliance with the valid cGMP provisions by conducting regular inspections. Furthermore, with respect to international projects, the relevant national authorities, such as the US-FDA are able to check for compliance to their specific regulations.

Our customers also regularly ensure compliance with cGMP provisions through audits.

GMP Certificate (human medicines) Bergheim
GMP Certificate (veterinary medicines) Bergheim
GMP-certificate Mainz (acc. to Art 111 (5) and 15 of directive 2001/83/EG)
GMP-certificate Mainz (acc. to Art 94 (1) of regulation (EU) 2019/6)
FDA Certificate Bergheim
FDA Certificate Mainz
Manufacturer´s Authorisation (Veterinary) Site Mainz (ger)