Regulatory Service 2017-11-10T13:21:00+00:00

Regulatory Service

Registration activities

Chemische Fabrik Berg is manufacturer of approximately 40 Active Pharmaceutical Ingredients which are marketed worldwide.

Beside further activities, the Regulatory Affairs department is responsible for the DMF registration of our different APIs in more than 30 countries (Europe, USA, Canada, Australia and others) and the support of our customers within the regulatory procedures.

Chemische Fabrik Berg is holder of approximately 20 DMFs. Certificates of Suitability (CEP or CoS) have been granted for six products by the European Department for the Quality of Medicines of the European Council.

Additional supporting activities of Chemische Fabrik Berg

Participation in the revision of monographs for products (EP, USP, BP)

Supply of reference standards of impurities and drug substances to the EDQM and USP