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Regulatory Affairs

The Quality and Regulatory Services Group (QRS) establishes the national and international regulatory basis for the worldwide use of the raw materials supplied by EMD Chemicals. It provides help and support in all questions relating to the various pharmacopoeias, to active substances and excipients used, as well as in all regulatory, quality and ISO/ACS aspects.

Since 1851, our products have been characterized by reliable, certified quality. The safety of patients and consumers alike has always been of the highest priority.

Our integrated Quality Management Systems (DIN EN ISO, 9001:2000, 14001, 13485, cGMP, etc.) reflect our understanding of quality. These standards have repeatedly been confirmed by audits carried out by the authorities and by our customers.

Specialists provide you with comprehensive help and support in all questions concerning regulatory affairs and quality, but also specifically on sensitive areas such as BSE/TSE, Aflatoxins, Allergens, GMO, cGMP, Residual Solvents, etc.


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EMD Chemicals is Merck KGaA, Darmstadt, Germany in the US and Canada.