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

Minimizing time-to-market and maximizing 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

Maintenance work support to improve processes and maximize productivity.

icono-pharmacovigilance

Pharmacovigilance

Case Management handling and implementing reporting tool. Providing support to set up a Quality system through PV system audits and QPPV services.

Specialists in:
Drugs  –  Biologics  –  ATMPs  –  Medical Devices

ASPHANEWS_2

Stay tuned! 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, etc.

Latest News

Brexit advice: Schedule a meeting with us!

January 18, 2021
Recently, we have received a lot of questions regarding Brexit and the changes it might imply for your business. Because of this, we are offering free consulting sessions with one of our Regulatory experts to discuss your projects and needs.

Sonia López- New Pharmacovigilance Director at Asphalion

January 15, 2021
Asphalion’s Board of Directors is pleased to announce the appointment of Sonia López as new Pharmacovigilance Director.

Marta Rayo Lunar- New Scientific and Regulatory Affairs Director at Asphalion

January 7, 2021
Asphalion’s Board of Directors is pleased to announce the appointment of Marta Rayo Lunar as new Scientific and Regulatory Affairs Director.

BREXIT | Latest updates in Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

December 21, 2020
As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.