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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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Stay tunned! Subscribe to Asphalion Newsletter

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

ASPHANEWS

Our 4th Asphanews is out now!

August 6, 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!
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Vicente Tur

Vicente Tur, New Regulatory Affairs Director at Asphalion

July 31, 2019
Asphalion’s Board of Directors announce Vicente Tur as new Regulatory Affairs Director of the company.
aspen campaign

Asphalion is commitment!

July 24, 2019
Last week, Aspahlion decided to collaborate with Aspen Pharmacare Spain in their campaign to help the the Fundació Banc dels Aliments de Barcelona in its food collection campaign “El Hambre No Hace Vacaciones”.