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Regulatory Affairs
In the field of active pharmaceutical ingredients, Laborchemie Apolda internationally cooperates with customers in Regulatory Affairs. Thus audits are not only performed by the TÜV Thuringia, the TLLV (Thuringian State Office for Food Safety and Consumer Protection; pharmaceutical department), but also by international customers and authorities.
Our service includes preparation and compilation, among other things, of Drug Master Files as well as CTD documents to be reviewed by authorities.
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