Quality Assurance

The quality assurance department secures the outstanding and constantly high quality of our active pharmaceutical ingredients. Thereby is the highest bid to strictly follow legal regulations. Our products and processes are developed according to current ICH- guidelines, corresponding to the needed FDA and EU requirements. At the same time our quality standards are permanently adapted to the continuously increasing and divers requirements on national and international level. The operational and organizational structure of our department is in accordance with the requirements defined in DIN EN ISO 9001. Our vision to continuously improve the quality standards is encouraged by regular inspections through competent authorities (for instance the local authority Regierungspräsidium Damstadt or the Food and Drug Administration, USA), our customers and relevant certifying bodies. In addition a self inspection system helps us to continuously improve the quality of our products and processes.

We act as a reliable partner for our customers for whom we offer high quality products and services which are developed according to especially adapted processes. The quality assurance system as well the GMP conform translation of instructions and processes are in accordance with valid standards and can be adapted within legal frames to the demands of our customers. Our biotechnologically produced active pharmaceutical ingredients are certified by a qualified person according to § 15 of the german drug law.

Highly qualified staffs with a long lasting gained experience in the field of pharma and GMP together with continuous training represent a central element in the safekeeping of our high level quality standards.