Regulatory Affairs

MOEHS_Quality_RegulatoryAffairs

MOEHS_Quality_RegulatoryAffairs

Moehs Group produces and sells more than 200 products worldwide in more than 90 countries. Among other activities, the Regulatory department is in charge of the Technical Assistance to customers and it is responsible of the DMF registration of our different APIs in more than 30 countries (including USA, Europe, Russia, Canada , Japan, Africa , Australia and New Zealand).

In fact, we are holders of more than 80 DMFs registered worldwide, 29 USDMFs filed at the FDA for the US market and 16 J-DMF filed in the PMDA for the Japanese market.

The European Department for the Quality of Medicines of the European Council has granted Certificates of Suitability for 30 of our products and there are 3 dossiers which are currently under assessment.

Moehs regularly collaborates with the European Pharmacopoeia and USP for the elaboration of new and revised monographs for several products

Additionally, Moehs periodically supplies to the EDQM and USP with reference standards of impurities and drug substances (CRS)