Since the finalization of the internationally harmonized guideline ICHQ7, the GMP-requirements for API manufacturing are clearly defined. Yet – time and again – many manufacturers have difficulties with its adequate interpretation and practical implementation.

We have acquired international and long-standing experience in the area of API manufacturing. Constantly delving into the most recent and continuously developing requirements, we are able to provide You with a custom-fitted and adequate interpretation of the regulatory demands, naturally including our practical implementation support.