Núria Coderch, Anna Graupera and Christopher Mann from Asphalion attended the last consortia meeting in Athens about the Horizon2020 project “Elastislet”

Lidia Cánovas and Marta Rayo from Asphalion presented the press conference about Asphalion participation in innovative medicines development

Our director of Regulatory Information, Remco Munnik, is one of the distinguished speakers in the upcoming CBI’s 2nd Annual IDMP Update Forum in Philadelphia on Dec 8-9

Saudi Arabia FDA (SFDA) is adopting a new product registration mechanism from 1st February 2017

Asphalion S.L. will form part of the database of Innovative SMEs in Spain until 2019.

Now is the time to plan ahead!

We hope that this will be the beginning of a successful collaboration!

Asphalion brings science to the market through regulation compliance.

Update on the developments in Europe for Regulatory Affairs and the impact on product development and life cycle management

“Jornada sobre la implementación del IDMP (Identification of Medicinal Products) y manejo de Datos” on 21st September in Barcelona.

eCTD and electronic submission will become mandatory on short future

After the holidays we have 3 important appointments, in which we can meet?

Keep up on the latest news, don’t miss it!

“Jornada sobre la implementación del IDMP (Identification of Medicinal Products) y manejo de Datos” on 5th July in Madrid

A new version of the EU eCTD Module 1 Specification (3.0.1) which can be used from 1st July 2015 and must be used from 1st October 2016.

From January 2017 EDQM will require eCTD submissions for new applications for CEPs

Did you know that Food and Drug Agency of Thailand is releasing new TH Module 1 with TH regional schema V1.0. eCTD submission?

The meeting was arranged in order to ask AEMPS some guidance in order to prepare the coming submission of the phase IIa clinical trial inside the iHIVARNA project.

Our team is attending now the inaugural conference.

New therapies for rare diseases: New EU project MYOCURE advances treatment of rare hereditary muscle disorders.

EXTEDO and ASPHALION invite you to their webinar “Pharmacovigilance Inspection Readiness in Spain: Electronic Safety Database” on 23 May 2016.

CataloniaBio is the association of companies in the health and life sciences arena in Catalonia.

The implementation and use of the electronic Aplication Form (eAF) and the RAEFAR electronic platform – 25th April at 10:00h GMT

Last news and services from Asphalion.

Our team attended the 28th Annual DIA Euromeeting on 6-8 April. After three days of presentations and meetings with clients, the results have been more than satisfactory.

Asphalion is delighted to offer an exclusive 25% discount to its clients, click here to get it!

Asphalion contributes in the development of a new therapy to treat Diabetes in a project called ELASTISLET

ASPHALION will be present at booth K11 of DIA’s 28th Annual EuroMeeting in Hamburg next April.

Asphalion is happy to announce that it has been certified by Health Canada to perform electronic submission by the Gateway.

EMA has just published a new version of QRD templates for product information (version 10 for CP and version 4 for MRP/DCP)

The first results with the first vaccinated patients are quite optimistic and the discussion on the phase II clinical trial was productive, setting the foundations for this second part of the project.

We hope you enjoy them as much as we do!