Pharmacovigilance European Local Contact Network
A network of qualified partners that allows ASPHALION to provide pharmacovigilance services throughout Europe
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.
EU Local Solutions
Strategies to maximize price and reimbursement, when applicable.
Schedule a free meeting!
Discuss your case with our experts and receive a valuable feedback
Share
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.
Related Resources
A network of qualified partners that allows ASPHALION to provide pharmacovigilance services throughout Europe
All what you need to know about the impact of MDR on Directive 2001/83/EC.
EU Pharmacovigilance local contact services case study. Small biopharmaceutical company with one
pharmaceutical product authorized through
a Decentralized Procedure in 10 European
countries.
The Client has all PV local activities
outsourced to different vendors in each
country, which poses several challenges.
This white paper examines the business drivers behind this shift and three factors that are critical to maximizing thebenefits of a unified RIM solution.
Asphalion’s directory provides a comprehensive guide to these bodies around the world.
Have a look at the slides to see how Asphalion´s expertise can help you with your regulatory processes. Our dedicated subject matter experts can provide you with successful, high-quality support
The scope of the policy relates to clinical data, composed of clinical reports and individual patient data (IPD), submitted under the centralised marketing authorisation procedure after the effective date (see chapter 4.3. for further information), either using the common technical document (CTD) format or another format
Services
Memberships & Partnerships
Quality Management System
© Asphalion
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
