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

Our services

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Regulatory and Scientific Strategy during Development

Minimize time-to-market and maximize 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

Support for maintenance work to improve processes and maximize productivity.

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Pharmacovigilance

Handling Case Management and implementation of reporting tool. Support to set up a Quality system though PV system audits and QPPV services.

Specialists in:
Drugs  –  Biologics  –  ATMPs  –  Medical Devices

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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, …

Latest News

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May 2020 | Only a few months remain for DoA of the new MDR

December 4, 2019
May 2020 is round the corner and therefore, only a few months remain for date of application (DoA) of the new medical device regulation (MDR).
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AsphaNews | Last newsletter of the year 2019 🌠

December 3, 2019
Take a quick look at our latest newsletter and keep up to date with the latest news and events on the regulatory affairs and pharma sector. Subscribe to our newsletter and become an expert in Regulatory Affairs!
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Asphalion attended the second edition of the “Forum d’Empreses de l’ámbit farmacèutic – sanitari“

December 2, 2019
Last week Asphalion attended the second edition of the “Forum d'Empreses de l'ámbit farmacèutic – sanitari“, organised by the Facultat de Farmàcia I ciències de l'alimentació de la Universitat de Barcelona.

MDR corrigendum | Manufacturers of Class I MD may have 4 years more to meet the regulation’s standards

November 28, 2019
The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s MDR giving manufacturers of Class I devices upclassified under the MDR a four-year transitional period until May 26, 2024, before they are required to meet the new regulation's standards.