Slider

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

Our services

Icono-regulatory

Regulatory and Scientific Strategy during Development

Minimize time-to-market and maximize cost efficiency by establishing the right strategy for the product development.

icono-medical-writing

Medical and Scientific Writing

Meticulous and consistent CTD dossier preparation to assure successful registration.

Icono-global

Global Submissions

Assessment of regional requirements based on experience and reliable coordination of local partners for global registration procedures.

Icono-esubmissions

eCTD and RIM

Comprehensive eCTD services by using advanced e-tools and efficient Information Management by implementing RIM solutions.

icono-life

Life-Cycle Outsourcing

Support for maintenance work to improve processes and maximize productivity.

icono-pharmacovigilance

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

Stay tunned! Subscribe to Asphalion Newsletter

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 - summer time 2020

Summer – Asphalion does not close in August!

July 31, 2020
We will be open in August and available to attend all your needs and requests as usual!
free meeting

2 clicks for a free 30-minute meeting!

July 27, 2020
Do you need regulatory support during your drug development? It has never been so simple to get it!

Craash Barcelona | Regulatory Aspects for Medical Devices by Dominique Monferrer

July 22, 2020
Dominique Monferrer, Asphalion’s Medical Devices Expert, was invited to give a talk on Regulatory Aspects for Medical Devices to participants of the 3rd edition of Craash Barcelona program.
rim system meetig with us

Are you thinking of implementing a RIM System?

July 21, 2020
Don’t you know how IDMP can affect the way you store your data? Do you need more information? Schedule a meeting with us!