Slider

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

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

dekra

DEKRA Certification GmbH | The first IVDR Notified Body

October 15, 2019
Two months after being designated as the third Notified Body (NB) under the Medical Devices Regulation (MDR), Dekra Certification GmbH was annouced last week by the European Commission (EC) as the first NB to be designated under the EU In Vitro Diagnostic Regulation (IVDR).
Stakeholders update meeting

Stakeholders Update Meeting

October 14, 2019
Last Friday, Stakeholders Update Meeting took place in Madrid and was a great success!
MDR

MDR | SSCP: a guide for manufacturers and notified bodies

October 10, 2019
With the entry into force of the new Medical Devices Regulation (2017/745/EU, “MDR”), many new requirements to be met by the manufacturers have been established.

January 2020 | EDQM will require eCTD submissions for all applications

October 8, 2019
As published in the Electronic submissions for CEP applications Revised Roadmap 2016-2020, from January 2020, EDQM will require eCTD submissions for all applications including requests for revisions and renewals (except for TSE only submissions and for submissions for substances for veterinary use only).