// Support in legal questions

We know the ropes in drug approvals and international regulations

Our range of services includes more than the production of our active pharmaceutical ingredients. AMINO offers a wealth of expertise in the field of regulatory affairs. We have competent experts who will gladly advise you at any time when it comes to the drug approval or the preparation of questionnaires. Do you need further information on one of our active ingredients? We have Drug Master Files or CEP certificates for all our products.

 

The approval of active pharmaceutical ingredients varies depending on the country and field of application. Nevertheless, we guarantee that AMINO products comply with the regulations and requirements of the relevant authorities at all times. This is because we are not only subject to pharmacovigilance by the Braunschweig Trade Supervisory Board, but have also successfully undergone inspection by the US Food and Drug Administration (FDA). It goes without saying that we hold a manufacturing license and a GMP certificate.

// Your contact persons

// Your contact for Regulatory Affairs

From the approval of drugs to the correct preparation of information – our experienced team supports you in the area of regulatory affairs. Nationally and internationally.

 

+49 5355 9100 19
regulatory-affairs(at)amino.de

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