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

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

mdr ivdr

Q&A document on the implementation of the MDR and IVDR

November 12, 2019
The EMA has recently revised the Q&A document that provides practical considerations concerning the implementation of the MDR and IVDR.

Graphene Connect on MedTech and Diagnostic Technologies

November 7, 2019
Yesterday, November 6, Dominique Monferrer and Eduardo Garrido participated in the event Graphene Connect on MedTech and Diagnostic Technologies associated with the first Graphene for Health Investment Forum.

Brexit | Very interesting and productive day!

November 4, 2019
Last week, Lidia Cánovas and Nuria Romero participated in the seminar “Els efectes del Brexit en el sector Farma".
Halloween and la castanyada

La Castanyada & Halloween in Asphalion

October 31, 2019
Asphalion is celebrating both events on the same day. Do you celebrate these festivities in your company too? Trick or Treat?