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Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Munich, Amsterdam and London.

Our services

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Regulatory and Scientific Strategy during Development

Minimizing time-to-market and maximizing cost efficiency by establishing the right strategy for the product development.

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Medical and Scientific Writing

Meticulous and consistent CTD dossier preparation to assure successful registration.

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Global Submissions

Assessment of regional requirements based on experience and reliable coordination of local partners for global registration procedures.

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eCTD and RIM

Comprehensive eCTD services by using advanced e-tools and efficient Information Management by implementing RIM solutions.

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Life-Cycle Outsourcing

Maintenance work support to improve processes and maximize productivity.

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Pharmacovigilance

Case Management handling and implementing reporting tool. Providing support to set up a Quality system through PV system audits and QPPV services.

Specialists in:
Drugs  –  Biologics  –  ATMPs  –  Medical Devices

ASPHANEWS_2

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Latest news, tips, advice and fresh perspectives on Regulatory Affairs including: deadlines, updates, FDA, EMA, innovative solutions, Brexit, eSubmissions, drug development, guidelines, ODD, strategic consulting, scientific, procedures, roadmaps, etc.

Latest News

Barcelona Innovation Day/ London 2020

Barcelona Innovation Day/ London 2020

November 25, 2020
Lidia Cánovas, General Manager of Regulatory Affairs at ASPHALION and Board Member of CataloniaBio & HealthTech, will be participating in the session “Clinical Development After COVID-19” at 4:20 pm (CET time).
Asphalion sustainable company

Asphalion receives medal for sustainability from EcoVadis

November 25, 2020
Asphalion is proud to announce that it has been awarded a medal for Corporate Social Responsibility from EcoVadis, the world’s most trusted provider of business sustainability ratings, intelligence, and collaborative performance improvement tools for global supply chains.
WEBINAR MEDICAL DEVICES

Webinar | “Introduction to regulatory aspects of IVD medical devices”

November 25, 2020
This morning Marta Rayo Lunar, Scientific and Regulatory Affairs Director at Asphalion, will give a talk on Clinical Evaluation/ Performance of IVD medical devices during the webinar “Introduction to regulatory aspects of IVD medical devices”.
Digital Health Panel Discussion

Digital Health Panel Discussion 2020 – “Overcoming top challenges in digital health”

November 20, 2020
From Asphalion, we would like to especially thank all the speakers for their contribution and all the attendees for their predisposition to active participation.