Regulatory Affairs


European drug market undergo rapid and constant transformation. As a result of this highly regulated and competitive market our network offers Regulatory Affairs services for medicinal products, medical devices, cosmetics and food supplements.

EuDRAcon partners can ensure regulatory compliance as well as take care of your pre- and post-marketing needs. We provide a full scope of regulatory services -we investigate, strategize, manage and compile all necessary data for the on-going maintenance of a medicinal product.

We work on both European and national levels to fulfil our clients’ expectations and demands for marketing authorisation applications, preparation and updating of SmPC, package leaflets and labelling, variations and renewals, readability and user testing and many more.