EU Local

Forget about the burdens: A robust management system of a strong network of partners to comply with local European regulations

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.

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.

Our Solutions

  • Local requirements adaptations’ for Module 1 of:
    • Management of national phases of DCPs and MRPs
    • Strategic consultancy in approaching Reference Member States.
    • Advisory on data compilation to be included in reports
    • Support in response to regulatory requirements, such as in Preliminary Regulatory Assessments adapted for each type of product
  • Communication and mediation with National Competent Authorities, including potential meetings to be carried out
  • Management of local portals and databases to ensure documents follow country-specific standards and formats
    • Mandatory activities before product launch: Regulatory consultancy, roadmaps and feasibility assessments to accelerate approval
  • Product life-cycle maintenance, including pharmacovigilance and compliance
  • Review of promotional materials according to local compliance
  • Submissions via electronic documents (eSubmissions)
  • MA transfers to other EU countries
  • Local variation renewals of National MA and document update

Strategies to maximize price and reimbursement, when applicable.

 

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Why Asphalion?

Asphalion has become a global Regulatory Affairs service provider with the capability to support your regulatory procedures across the EU at a country level through an expert and 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 success in all your local duties as Marketing Authorisation Holder.

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