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

Last call to apply for H2020 programs in 2017!

February 24, 2017

We can help you with our experience in Horizon 2020 programs and be your regulatory partner

FDA Open Seminar 2017: Opportunities Ahead

February 23, 2017

Save the date for the event taking place on 1-2 June 2017 in Barcelona!

Asphalion is participating in HIVACAR H2020 project

February 17, 2017

Asphalion is one of the members of the new European project consortium aimed at obtaining a functional cure for HIV with immunotherapy

Successful eSubmissions to FDA

February 14, 2017

The FDA Electronic Submissions Gateway (ESG) enables the secure submission of regulatory information to the proper FDA Center or Office

ISO IDMP EMA official guidelines

January 25, 2017

The ISO IDMP standards establish definitions and concepts, and describe data elements and their structural relationships in order to build the unique identification of the medicinal product.

Asphalion renews its corporate image

January 23, 2017

Asphalion is excited to announce the implementation of our new corporate image.

Join us in eRegulatory Summit event and get a discount!

January 23, 2017

Asphalion is proud to be the sponsor of the event and we are pleased to invite you to participate at a reduced rate

Mandatory FDA Data Standards for Clinical and Non-clinical Studies

January 23, 2017

Study data standards will be required for most study data submitted to FDA’s

FarmaForum 2017

January 20, 2017

Asphalion is participating in the congress and our General Manager in Regulatory affairs Lidia Cánovas will run a specilized workshop.

Join us in eRA event and get a discount!

January 19, 2017

Asphalion is proud to be the sponsor of this event and we are pleased to invite you participating

Denmark phasing out NeeS

January 2, 2017

Mandatory eCTD format for national marketing authorization applications for medicinal products.

Welcome 2017!

December 23, 2016

Wishing you a happy Christmas and a prosperous new year from the Asphalion team. 

Mandatory eCTD for National Applications in Austria

December 12, 2016

From 1st January 2018, new National applications in Austria, must be submitted in eCTD format.

Medicines for Europe 16th Regulatory and Scientific Affairs Conference in London!

December 1, 2016

Asphalion is proud to be the sponsor of the Telematics Workshop on 25th January 2017. Our Regulatory Information Director, Remco Munnik, will be the expert speaker of ISO IDMP conference.