Technical Rejection Criteria for Study Data in US FDA

July 6, 2018

Avoid validation errors when submitting NDAs, BLAs, ANDAs and INDs study data by implementating required standards

Update on serialization activities

June 26, 2018

Implementation of safety devices in medicinal products for human use applicable in AEMPS as of 9th February, 2019

Is human plasma used in the manufacture of your products?

June 25, 2018

Do you want to obtain the Plasma Master File (PMF) certification?

Relive the FDA Open Seminar 2018 with this summary!

June 12, 2018

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

The new medical device’s nomenclature

May 25, 2018

To support the functioning of the future European Database on Medical Devices (EUDAMED)

Countdown for FDA Open Seminar 2018

May 23, 2018

All you need to know – Success for development and registration
(7-8 June, Barcelona)

Asphalion participates at the 2nd Annual Meeting of the MYOCURE project

May 22, 2018

MYOCURE is a H2020 project that aims at developing new therapeutic products based on gene therapy for patients suffering from rare inherited muscle diseases

Asphalion participates in the follow up meeting of nTRACK project

May 22, 2018

nTRACK is a H2020 project that aims at multimodal nanoparticles for structural and functional tracking of stem cell therapy on muscle regeneration

HIV Vaccine Awareness Day

May 18, 2018

Asphalion is actively participating in two EU funded projects aimed at developing the HIV infection cure

Two years of PRIME

May 11, 2018

EMA has presented the results of the scheme to enhance support for the development of medicines that target an unmet medical need

Pharmaceutical sector in the post-Brexit era

May 3, 2018

Consequences of UK becoming a “third country”

Last Call for DMFs and INDs

April 20, 2018

eCTD becomes mandatory on 5 May 2018

Updated eSubmission Roadmap

April 19, 2018

Check up on the main updates compared to version 2.0

Implementation of the Canadian Labeling in XML format

April 4, 2018

Structured Product Monograph initiative in Health Canada

Asphalion expands their team of experts to Madrid

March 20, 2018

It is Asphalion’s second office in Spain, after the opening in Munich

Update on the MDR/IVDR transitional period

March 15, 2018

Notified bodies and medical device manufacturers are facing many challenges until the full applicability of the new MDR and IVDR Regulations

Asphalion attended Nit de CataloniaBioHT 2018

March 9, 2018

As proud members of the association we attended the annual dinner

New release EMA Gateway version

March 8, 2018

The European Medicines Agency has released a new version of the Gateway (v3.4.0.0) with minor but significant additions/changes

Rare Disease Day 2018

February 28, 2018

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

El formato eCTD ya está aquí!

February 2, 2018

¿Cuáles son las principales ventajas de eCTD sobre NeeS o el papel? ¿Cómo comienzo mi baseline? ¿Cuáles son las fechas de implementación? ¡Conoce todos los detalles de las eSubmissions obligatorias!

The eCTD format is already here!

February 1, 2018

What are the main advantages of eCTD over NeeS or paper? How do I start my baseline? What are the timelines?
Find out all the details of the mandatory electronic submissions!

Treating Rare Hereditary Muscle Disorders: MYOCURE Partner Interviews Provide Research Insights

January 29, 2018

Asphalion participates in the MYOCURE H2020 project as a regulatory partner

Team Asphalion is taking part in Oxfam Trailwalker

January 18, 2018

We want to share this challenge so that everybody can be part of our cause!
100 km, 1 cause – 14-15 April 2018, Girona

Asphalion registered for electronic submissions to the Center for Veterinary Medicine of FDA

January 11, 2018

Asphalion is happy to announce that it has been registered by FDA to perform electronic submission to the CVM by the Gateway

New steps to facilitate efficient generic drug review in FDA

January 10, 2018

New guidances help ANDA applicants avoid common deficiencies

In 2018, eCTD mandatory for new CEP applications

January 5, 2018

EDQM will stop accepting PDF submissions for revisions and renewal applications in 2018

FDA may “Refuse to File” your NDA/BLA submission

January 4, 2018

New draft guideline clarifies the circumstances where an application can be “Refuse to File”

Welcome 2018!

December 21, 2017

Wishing you a Happy Christmas and a prosperous New Year from all Asphalion team

4th Photo Contest Asphalion

December 19, 2017

Enjoy the most outstanding pictures included in Asphalion calendar for next year!

Asphalion in attendance as the nTrack H2020 project kicks-off in Barcelona

December 18, 2017

The four year Horizon 2020 nTrack project to develop nano-imaging reagents for stem cell tracking and biodistribution is now underway with Asphalion as regulatory partner.

CAMD Implementation Taskforce

December 7, 2017

Key issues to be addressed as part of the implementation of MDR and IVDR