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

January 13, 2020
UPDATE: The corrigendum for the EU’s Medical Devices Regulation (MDR) granting manufacturers of Class I devices upclassified under MDR a four-year transitional period has been approved and published.
Formatted Letter Template

Formatted Letter Template | No longer maintained by EMA

January 9, 2020
As from January 1st 2020, the Formatted Letter Template used in CP applications is no longer maintained by EMA.

Asphalion team wishes you a Merry Christmas and a Happy New Year

December 19, 2019
2020 is very special for us as we will celebrate the 20th Anniversary of Asphalion. Thank you for being part of it!
medical devices

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).