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!

Asphalion in FDA!

May 25, 2017

Our experts were in Washington last May 23rd to attend a Pre-IND meeting in the FDA

Asphalion participated in the 3rd European Oncology Business convention

May 23, 2017

Our experts attended the Meet2Win Congress in Bordeaux last week

Be aware about the new European Regulatory Framework of Medical Devices

May 22, 2017

Keep following us and be updated on all changes and implementation plans.

Fifth Progress Meeting of H2020 ELASTISLET project

May 15, 2017

Partners met in Basel for an update on project achievements

Join our free webinar “Speed up Spain – An approach to Regulatory procedures in Spain”

May 15, 2017

Get an update on the latest Spanish portal RAEFAR requirements and other national regulatory topics

eCTD format already mandatory in FDA

May 10, 2017

Since 5th May 2017 eCTD format became mandatory for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs) and Biologics License Applications (BLAs).

Asphalion’s Quality Management System has been certified

May 10, 2017

We are proud to announce our successful certification in ISO 9001:2015

No grandfathering is going to be valid at this time?

May 5, 2017

Are you ready for implementing the changes? All devices in the market must be compliant with the new Regulations at the end of the transition period.

Self-Identification of Generic Drug Facilities, Sites, and Organizations for fiscal year 2018

May 2, 2017

FDA reporting period for self-identification opens May 1st to June 1st of 2017

Are you aware of the new Medical Devices Regulations?

April 28, 2017

Get ready for the upcoming changes! We are organizing an on-line webinar to assist you about their implementation.

FDA Extends Deadline for Submitting DMFs in eCTD format

April 19, 2017

NDAs, BLAs, and ANDAs eSubmission deadline is maintained for next May 5th 2017

Register for Advanced European Regulatory Affairs course!

April 10, 2017

Get an update on the latest developments on regulatory affairs and their impact on product developments and life cycle management

New EU rules on medical devices to enhance patient safety and modernise public health

April 6, 2017

The Commission welcomes the adoption of its proposal for two Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety – Brussels, 5 April 2017

FDA and EMA harmonize plant inspections

March 15, 2017

Both regulatory agencies will rely on each other?s inspections improving resources efficiency

Preclinical results of iHivarna FP7 project public available

March 13, 2017

Asphalion’s involvement in cutting-edge research and innovation projects

Considerations for developing EU risk management plans

March 2, 2017

Maximize the utility of RMP to optimize the marketing authorization process of your product!

Today is the world Rare Disease Day!

February 28, 2017

Asphalion is involved in many projects related to the investigation and treatment of rare diseases