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

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.

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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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

The 39th Symposium of AEFI will be there soon!

February 21, 2019
This year, the meeting will be taking place from 14-15 March 2019 at the Hotel Sants Barceló, Barcelona. We are delighted and proud to announce that Asphalion experts will actively participate in the conference.

FDA: Type III DMF mandatory from 5 May 2020

February 20, 2019
FDA updated the guideline for Providing Regulatory Submissions in Electronic Format to reflect that the requirement for Type III drug master files (DMFs) to be filed electronically takes place 60 months after May 5, 2015.

EMA released validation checklist for initial MAA of the Centralised Procedure (CP)

February 19, 2019
Currently, validation issues occur in 90% of initial marketing authorisation applications (MAAs).  These validation issues create additional workload for companies and potential delays at a critical moment for the timely start of the procedure.

Brexit, is the Pharmaceutical Industry ready for Brexit?

February 18, 2019
There is few time left until end of March and there are still quite some uncertainties with regards to the Brexit. Asphalion can assist with the RMS transfer and provide EU QPPV, PSMF establishment and SME registration within the EU.