EU Local

In spite of the existence of centralized procedures that span across all countries within the European Union, registration and commercialization of therapeutic products is sometimes focused on concrete countries based on companies’ strategic decisions. This usually involves an adaptation of marketing strategies to local regulatory frameworks and stakeholders for Decentralised Procedures (CDPs), Mutual Recognition Procedures (MRPs) and National-based procedures (NPs).

At Asphalion, we offer specific solutions based on each regulatory environment, both from the start of a new marketing authorization to the adaptation of a preexisting one to new markets. Asphalion has become a global Regulatory Affairs service provider with the capability to support your regulatory procedures in all EU countries at a local level through an expert, qualified network of partners with strong knowledge of local legislation and regulatory specificities. Asphalion´s team, together with native speakers will guide you to achieve the success in all your local duties as Marketing Authorisation Holder.