Frithjof Holtz Merck KGaA

Frithjof Holtz is a biologist and has been working for more than 28 years with Merck KGaA, Darmstadt, Germany, having years of experience in quality assurance and regulatory affairs. Besides experience in chemical manufacturing (excipients/APIs), he has also working experience in quality assurance for drug products (sterile/non-sterile).

Furthermore, Frithjof has been working for more than 13 years in Regulatory Affairs (CMC) for pharmaceutical starting materials and consumables and their regulatory needs for their use in sterile/non-sterile drug product manufacturing and registration.

Currently, he is responsible for the coordination of the advocacy & surveillance activities for Merck Life Science. In this role, he has gained additional expertise in regulations on sterile/biopharma drug substance/products. Besides this, Frithjof has many years of experience in working in industry associations as in Rx-360, APIC, EFCG, IPEC and PDA.