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

Gestión óptima de expedientes electrónicos con varias dosis o formas farmacéuticas – Curso Online

July 7, 2020
El próximo 14 de julio, Vicente Tur llevará a cabo el curso online “Gestión óptima de expedientes electrónicos con varias dosis o formas farmacéuticas” organizado por AEFI.
medical devices

Asphalion attended the online session “Improving Human Health Through Artificial Intelligence”

June 30, 2020
Rainer Rothe, Scientific and Regulatory Affairs Officer at Asphalion, attended the online session “Improving Human Health Through Artificial Intelligence” organised by CataloniaBio & HealthTech.
dia europe 2020

DIA Europe 2020

June 26, 2020
Next week, from 29 June to 3 July, Asphalion will participate in the DIA Europe 2020.
meeting

Schedule a meeting with us: New tool on our website!

June 25, 2020
Asphalion is committed with digital transformation and in easing the digital connection with you. From now on, you can request a meeting with our team with just two clicks.