All pharmaceutical and biological products are governed by strict regulations set by the relevant regulatory authorities in the respective countries and regions of the world. Ferring’s Regulatory Affairs department at IPC in Copenhagen [url: "/en/randd/RandD+Centres/Copenhagen.htm" ] has built up considerable expertise in dealing with the regulatory authorities1 all over the globe.
Ferring must obtain a marketing authorisation2 for every new product it develops. In order to obtain approval to market a product from a regulatory authority, Ferring must submit all data generated by pharmaceutical analysis, pharmaceutical development [url: "/en/randd/Creating+New+Medicines/Drug+Development/Product+Development.htm#pharmadev" ], non-clinical development [url: "/en/randd/Creating+New+Medicines/Drug+Development/Product+Development+more.htm#nonclinical" ] and clinical testing of the product to the regulators so that they can independently assess the quality, safety and efficacy of the product. All the data have to be submitted and presented in a specified format known as a Common Technical Document (CTD).
Ferring’s Regulatory Affairs department is responsible for preparing and submitting applications for approval of therapeutic products, managing and updating all relevant dossiers, and for relations with regulatory authorities. The enormous amount of data generated during the development of a compound is organised, preferably electronically, in a regulatory dossier, according to the format specified by the relevant authorities.