ASPHALION´S HIGHLIGHTS | Second quarter 2024
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The European Union represents an important marketing opportunity in terms of dimensions thanks to the existing common regulations among countries via the centralized procedures. The pharmaceutical regulation in this region is governed by supranational bodies, such as the EMA and its working parties and associate partner authorities.
To succeed in the approach to these entities, a correct designation of the product and a detailed strategy about the best way to contact, timings, meeting preparations, obtention of proper advice, management of CTAs, among others, are crucial to achieve an accelerated approval.
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Why Asphalion?
With 20+ years track record in handling submissions, Asphalion provides reliable support for all type of regulatory procedures in Europe. We provide regulatory strategy to anticipate any potential hurdle, coordinate your submissions and liaise with European agencies until the approval of the Marketing Authorisation.
Main benefits
Asphalion has large experience in writing, submitting and updating all types of technical dossiers specified for each product type including:
Furthermore, Asphalion has a proven track record and experience in following tracks, timings and standard formats in centralized submission procedures involving all intervenient regulatory entities.
Related Resources
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Highlights video
IND preparation and submission business case: A small European biotech company focused on drug discovery and development interested in engaging with the FDA.
Asphalion contributions to the fight against COVID-19
A guide to have an overview of regional submissions requirements
(CTR) No 536/2014
A network of qualified partners that allows ASPHALION to provide pharmacovigilance services throughout Europe
Scientific & Regulatory Affairs Support during development of ATMPs & Biologics
Navigating Local Pharmacovigilance in European Countries, UK and Switzerland.
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.
At ASPHALION we are pleased to announce our participation in RAPS EuroConvergence 2025, one of the premier regulatory affairs events in Europe. This year’s conference will be held at the
Last week, ARDAT project members gathered in Barcelona for the project’s General Assembly. The ARDAT project is focused on accelerating the research and development of Advanced Therapy Medicinal Products (ATMPs)
We are pleased to announce that ASPHALION will participate in the third edition of Connection Day, organised by Catalonia.Health, which will take place on April 29th at the World Trade
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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