Àrea Clients / Col·laboradors

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La indústria farmacèutica és un model de negoci totalment regulat. Gestionar les sol·licituds d’autorització és una de les funcions principals del departament de Registres o Regulatory Affairs, la qual cosa és essencial perquè els productes entrin al mercat.

Sense l’autorització prèvia de l’Autoritat Sanitària competent, no es pot comercialitzar cap medicament. Els requisits poden variar en funció del tipus de producte que es vulgui comercialitzar (medicaments, productes sanitaris, cosmètics, complements alimentaris, etc.).

L’Agència Europea de Medicaments (EMA), per exemple, demana que els resums de les fitxes tècniques, els prospectes o l’etiquetatge, entre d’altres, s’entreguin en les llengües de tots els estats membre on es comercialitzi el producte. Així mateix, obtenir llicències en altres països del món pot implicar haver de complir amb altres requisits lingüístics imposats per les autoritats competents.

Degut a la naturalesa tècnica, confidencial i reguladora dels diversos documents i textos que es tradueixen, els nostres traductors i revisors coneixen plenament el vocabulari especialitzat així com els procediments que es descriuen en els textos que tradueixen. D’aquesta manera, la traducció és clara, concisa i fidel a l’original.
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• Informes de qualitat
• Informes de posicionament terapèutic
• Procediments normalitzats de treball
• Adaptació de resums d’assajos clínics per a persones llegues
• Estudis d’usabilitat

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• Anàlisis per lots
• Protocols de validació de fabricació
• Etiquetes de producte
• IFUs
• Prospectes
• Fitxes tècniques

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• Avaluacions de biocompatibilitat
• Validació de processos
• Informes d’expert clínic i preclínic
• Protocols de processos i d’estudis clínics
• Dossiers de registres
• Avaluació de riscos

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MDR is the new set of regulations governing the production and distribution of medical products in Europe. In this article, we tell you all about this new regulation.