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

Asphalion in MedTech Summit 2019

June 21, 2019
On Monday and Tuesday, Lidia Cánovas and Dominique Monferrer participated in the MedTech Summit 2019.

FREE WEBINAR: Bases de datos de Farmacovigilancia: ¿qué debe saber IT?

June 21, 2019
No pierdas nuestro próximo webinar que tendrá lugar el día 28 de Junio de 11 - 12 horas.

News on Medical Devices

June 17, 2019
A new version of the MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES has recently been published by the EU Commission (version 1.22, 05-2019).

Asphalion Open Doors was amazing!

June 14, 2019
The first edition of Asphalion Open Doors took place last 7th June in Barcelona!