New version of the EMA EudraVigilance to be launched on 22nd November

October 26, 2017

Improved system with enhanced features for reporting and analysis of suspected adverse reactions related to medicines


New offices in Madrid

October 20, 2017

Asphalion closer to AEMPS

We are hiring!

October 19, 2017

Are you interested in working at Asphalion? See our current job offers and apply to join our team!

pharmacovigilance data entry

New requirements on Pharmacovigilance Data Entry!

October 16, 2017

New obligations on signal management and reporting of suspected adverse reactions will apply since November 2017

Condemn any form of violence

Condemn any form of violence

October 3, 2017

After the events that took place this Sunday, the 1st of October in Catalonia, Asphalion wants to condemn any form of violence.

New FDA Gateway in Production Environment

New FDA Gateway in Production Environment

September 28, 2017

Since September 18th Production FDA ESG 2nd generation is live

cphi worldwide

Asphanews September!

September 14, 2017

Welcome back! It’s time to keep updated on the latest news of Asphalion and pharma sector

post-authorisation measures (PAM)

EMA has implemented a new submission form for post-authorisation measures (PAM)

September 7, 2017

Asphalion can assist you with the PAMs of your centrally authorised product!

fda submissions

How to include the REMS for NDAs, ANDAs and BLAs in SPL format?

September 7, 2017

FDA has just released a the guide to include them and in two years it will become mandatory

world pharmacists day 2017

World Pharmacists Day 2017

September 7, 2017

Asphalion is joining the cause on September 25th to highlight the great contributions the pharmacy profession is making to healthcare

Global Pharmaceutical Regulatory Affairs Summit 2017

Global Pharmaceutical Regulatory Affairs Summit 2017

August 29, 2017

Get an exclusive 25% conference discount by using Asphalion’s VIP code CQ5267ION

FDA User Fees have been reauthorized

FDA User Fees have been reauthorized

August 22, 2017

Get an update on the FDA Regulatory Affairs by joining our webinar!


Asphalion participated in the 8th General Assembly Meeting of the iHIVARNA’s project in Paris

August 21, 2017

The meeting focused on the phase I clinical trial, the ongoing phase II clinical trial, and next actions to be taken

We are all Barcelona

We are all Barcelona

August 18, 2017

Asphalion rejects violence and terrorism and wishes to give condolence to all families. We want to offer all our support in these difficult moments

Asphanews July!

July 28, 2017

Keep updated on the latest news of Asphalion and enjoy summer!

Free webinar on FDA Regulatory Affairs!

July 27, 2017

Based on the successful FDA Open Seminar conference series, we’ll host a 2 hour crash course webinar. You will hear about the latest US drug regulation news and will obtain a solid introduction into FDA Regulatory Affairs.

Are you attending CPhI 2017?

July 20, 2017

Visit Asphalion at booth 91B30 or arrange a meeting with us in advance!

ELASTISLET and Asphalion attend Innovation Task Force meeting with the EMA

July 19, 2017

This H2020 project is aimed at developing a smarter strategy to cope with diabetes

Asphalion submitted to the EMA the first Scientific Advice of the MYOCURE project

July 12, 2017

The project aims at developing an innovative gene therapy platform to cure rare hereditary muscle disorders

Asphalion Annual Convention was celebrated last June!

June 29, 2017

Funny team building activities on an exciting unique day

Barcelona official candidate for European Medicines Agency

June 28, 2017

Asphalion supports the initiative to host the EMA headquarters in Barcelona

SPOR, IDMP & ROG updates from the meeting with EMA

June 21, 2017

Last week, Remco Munnik, Asphalion´s Regulatory Information Director, attended the meeting at EMA for S&P subgroup and the Regulatory Optimization Group (ROG)

Asphanews June 2017

June 20, 2017

Keep up on the latest news of Asphalion!

MYOCURE progress meeting in Barcelona

June 20, 2017

During the two day meeting, the partners presented and discussed vividly the work and progress within the work packages, laying a thorough basis for the second year of the project.

Free Webinar! Data extraction from SmPCs into structured data for ISO IDMP compliance

June 20, 2017

It will take place next 7th July at 10.00 a.m. (CET) and it is organized by Ontopharma, Extedo and Asphalion

The EMA received in 2016 the highest number of initial applications for biosimilars

June 15, 2017

Asphalion has large experience in Biosimilars and is glad to highlight this positive trend in EU

Igenomix receives EMA Orphan Drug Designation for its product indicated for Asherman’s Syndrome with Asphalion support

June 14, 2017

Igenomix, a company leader in reproductive genetics and experts in infertility problems announced that its product autologous adult bone marrow-derived non-expanded CD133+ haematopoietic stem cells (IGX1) was granted the Orphan Drug Designation (ODD) on March 15th 2017 by the European Medicines Agency (EMA). The product is aimed at the treatment of patients with the Asherman’s syndrome (AS), a rare disease defined by the presence of intrauterine adhesions.

New Medical Devices Regulations Implementation Plan

June 14, 2017

Get ready for the upcoming changes! We are organizing a free webinar to assist you about their implementation, don’t miss it! 12th July at 15h CET.

EDQM Latest News!

June 9, 2017

New Application Forms & Submission Portal

Revive the FDA Open Seminar 2017 with this summary!

June 8, 2017

We are grateful to all attendees and speakers for making this edition a success

Mandatory eCTD

June 6, 2017

eCTD is becoming the obligatory standard throughout the world…(FDA, HC, EMA, EU, GCC, etc). For this reason, we are contacting you to offer our support!