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, 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.