Authorisation procedures/ market access


When dealing with regulatory matters in the context of authorisation procedures, too, we cover the wide range from foods to pharmaceuticals and cosmetics. We support our clients facing national and international authorities – if need be with the help of RDA Scientific Consultants GmbH. Key topics with regards to foodstuffs are for example the authorisation of additives (Regulation (EC) 1333/2008), health claims (Regulation (EC) 1924/2006) and novel foods (Regulation (EC) 258/1997). For the pharmaceuticals, the focus is placed on regulatory support in the context of the national or central European authorisation or registration of pharmaceuticals including orphan drugs, as well as conformity assessment procedures for medical devices. We also possess the needed expertise in other regulated market access procedures like compassionate use programmes. Furthermore, we provide assistance to our clients regarding all matters of market access, especially with respect to early benefit assessments for price formation (AMNOG).