A marketing authorisation may only be granted to an applicant established in the European Community (Art 8 2001/83/EC). The legal entity of ADOH is available to act as the formal marketing authorisation holder for your medicinal product marketing authorisations in any EU/EEA country. This offers also possibility to European companies to develop your business discreetly.
ADOH has a state-of-the-art pharmacovigilance system available in order to comply with all EU pharmacovigilance requirements for your human and veterinary medicinal products, including local contact persons in those EU member states where this is obligatory.
Together with DADA Consultancy regulatory affairs experts we are able to manage complete CP/DCP/MRP/NP registration procedures on your behalf.