Licenses

Overview of local and foreign authority inspections

Richter-Helm BioLogics holds GMP certificates and a number of manufacturing licenses from the relevant German authorities. Our Facilities have also been approved by international authorities (e.g. US FDA, Japanese PMDA, ANVISA in Brazil, and MFDS in South Korea)

As a Germany-based company, Richter-Helm BioLogics is regularly audited by the German authorities every two years to ascertain compliance with EU GMP regulations. In addition, in recent years Richter-Helm BioLogics has been audited multiple times by international agencies without any major non-conformances whatsoever. An audit by the Taiwanese authorities was paper-based.

Audit History by Regulatory Agencies and Clients

Audit history
Audit history

In addition, since 2007 we have passed around 70 client audits.