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

Our services

development

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

ASPHANEWS_2

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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

myocure

Asphalion participates at the 3rd Annual Meeting of the Myocure project

April 10, 2019
Asphalion participated in the 3rd Annual Meeting of the H2020 project MYOCURE, the 28th and 29th of March at the Ruprecht-Karls-Universität, in Heidelberg, Germany.
WORLD HEALTH DAY

World Health Day 2019

April 8, 2019
Yesterday was the World Health Day!
dominique monferrer

Dominique Monferrer in the Eurecat Conference

April 5, 2019
Dominique Monferrer, Asphalion’s Medical Devices Expert, was invited by Eurocat to give a talk on "Aspectos regulatorios en el desarrollo de productos sanitarios”.
brexit

EMA has published a Q&A document to answer Brexit questions

April 1, 2019
In order to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU (Brexit), EMA has published a questions-and-answers document for patients, healthcare professionals and the general public.