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

Our services


Regulatory and Scientific Strategy during Development

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


Medical and Scientific Writing

Meticulous and consistent CTD dossier preparation to assure successful registration.


Global Submissions

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


eCTD and RIM

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


Life-Cycle Outsourcing

Support for maintenance work to improve processes and maximize productivity.



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

Asphalion - summer time 2020

Summer – Asphalion does not close in August!

July 31, 2020
We will be open in August and available to attend all your needs and requests as usual!
free meeting

2 clicks for a free 30-minute meeting!

July 27, 2020
Do you need regulatory support during your drug development? It has never been so simple to get it!

Craash Barcelona | Regulatory Aspects for Medical Devices by Dominique Monferrer

July 22, 2020
Dominique Monferrer, Asphalion’s Medical Devices Expert, was invited to give a talk on Regulatory Aspects for Medical Devices to participants of the 3rd edition of Craash Barcelona program.
rim system meetig with us

Are you thinking of implementing a RIM System?

July 21, 2020
Don’t you know how IDMP can affect the way you store your data? Do you need more information? Schedule a meeting with us!