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Exclusive Event:
1st  Asphalion Open Doors, 7th June

First edition of #AsphalionOpenDoors, the unique annual event organized by Asphalion! This event will provide a structured introduction to all important aspects of Scientific & Regulatory Affairs world and will give you the opportunity to visit our new offices in Barcelona. 7th June 2019!
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Headlines & Breaking News

New Notified Body designated to issue CE Mark under EU MDR

On 22th May 2019, the Germany-based company TÜV Süd became the second notified body (NB) to be designated and notified under the EU Medical Devices Regulation (MDR). 
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EU measures in support of generic pharmaceuticals producers

The European Union adopts regulation to promote the competitiveness of EU producers of generic medicines and biosimilar products. 
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Fighting diabetes: TERMIS EU 2019 in Rhodes

The conference Tissue Engineering Therapies: From Concept to Clinical Translation & Commercialisation organised by TERMIS took place last week in Rhodes and was a great success!
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Missed our last webinar?

On 16th May, ASPHALION and Dora Wirth Languages Ltd. (DWL) had a live  webinar to guide you through the process of the Centralised Procedure (CP). If you missed out, don’t worry! The full webinar recording is now available on Asphalion Youtube channel.
About Us
Asphalion is companionship 
Annual Team Building Day

Asphalion is passion, flexibility, quality, commitment…but above all, Asphalion is companionship. Last week, the Asphalion’s annual team building took place in Barcelona.
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Asphalion Service 
Medical Devices Service

Asphalion wants to be your regulatory partner for Medical Devices. Our team provide comprehensive support during development, validation, certification and manufacturing of Medical Devices (MD) in Europe and the United States. 
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Asphalion Service 
ATMPs and Biologics Service

Asphalion provides comprehensive support during development of Advanced therapy medicinal products (ATMPs) and Biologics in Europe and the United States. We are experts in: Gene Therapy, Cell Therapy, Therapeutic Vaccines, Antibodies. Tissue Engineered Products, Nanoparticles, Biomaterials and Biosimilars
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Meet us!
7 June, Asphalion Open Doors, Barcelona, Spain
26-27 June, eSubmission Manager in Europe, Amsterdam, Netherlands
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