Atlas Molecular Pharma receives EMA and FDA ODD for CEP with Asphalion support

December 11, 2018

Atlas Molecular Pharma, a company specialized in the discovery and development of first-in-class, innovative therapeutics for the treatment of Rare and ultra-Rare Diseases, announced that its candidate drug Ciclopirox (L2.7.D7) was granted the ODD status on January 17th 2018 by the European Commision and on 17th April 2018 by the FDA.

Life isn’t all about work!

December 5, 2018

Yes, you can ask: “What is the relationship between Henri de Toulousse-Lautrec and Asphalion?” or “Is Asphalion changing its core business to Regulatory Affairs from Art Consultancy?”

Gran acogida del primer Open Seminar sobre Transformación Digital organizado por Asphalion y EXTEDO

December 4, 2018

El evento tuvo lugar en Barcelona y Madrid, y contó con más de 100 participantes de 50 empresas distintas, todas ellas con sede en España. ¡Gracias a todos por vuestra participación!

I Curso de Biomarcadores en Reumatologia

November 23, 2018

Last weekend, Asphalion took part in the I Curso de Biomarcadores en Reumatologia.

Eudravigilance System

November 22, 2018

The new Eudravigilance system has been in operation since 22nd November 2017.

EMA public consultation

November 20, 2018

EMA published for public consultation a guideline on quality, non-clinical and clinical aspects of medicines containing genetically modified cell.

News in paediatric pharmacovigilance

November 16, 2018

EMA made public the new good pharmacovigilance practice (GVP) chapter IV that offers an integrated view of pediatric pharmacovigilance.

Asphalion participated in the first Regulatory Affairs Workgroup launched by CataloniaBio & HealthTech

November 5, 2018

CataloniaBio & HealthTech launches Regulatory Affairs Workgroup

Asphalion is part of one of the new working groups of AEFI

November 5, 2018

Do not miss the latest news from eCTD, xEVMPD and all electronic formats.

We attended the meeting with the EMA’s Innovation Task Force

October 30, 2018

We participated in the 12 month meeting of the H20H20 project nTRACK.

New UDI MDCG guidances for Medical Devices

October 30, 2018

Unique Device Identification (UDI) is a new requirement set out in Article 27 and Article 24 (Unique Device Identification system) of both the new Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro diagnostic Device Regulation (EU) 2017/746 (IVDR), respectively.

EMA made it mandatory to use IRIS portal in order to apply for an Orphan Drug Designation (ODD)

October 18, 2018

In order to access this portal it is necessary to have an active EMA account as well as having the affected organisation currently registered in OMS (Organisation Management System).

Asphalion moves to a new office in Barcelona!

September 26, 2018

We keep growing to give the best of us!

See you at Biospain 2018 in Sevilla next week!

September 18, 2018

See you at Biospain 2018 in Sevilla next week! Chat with our regulatory experts Lidia Cánovas, Marta Rayo Lunar, Elisenda Gendra Molina PhD MSc, Oriol Penon and Marina Passarell Rubio and have a free coffee or a healthy juice with them! #Quality #Passion #WeAreAsphalion  

We are ready to overcome your challenges!

September 5, 2018

Finding solutions to the impossible, we are Asphalion.         #Passion #Flexibility #Commitment #Quality #Companionship 

Check out our free webinars!

September 4, 2018

Stay tuned to Asphalion’s activities!

Simplifying the Management of Complex SPOR Data

September 3, 2018

Save the date and join our FREE WEBINAR on 13th September at 10:00 – 11:00 (CEST)

New 3rd Acknowledgement for CBER Submissions

August 29, 2018

3rd Acknowledgement indicates if your submission has pass preliminary validation or notes any errors that occurred during validation

Are you looking for a Horizon 2020 regulatory partner?

August 8, 2018

Deadlines are fast-approaching, Asphalion can be part of your consortium

Supporting medicine developers

August 1, 2018

EMA tools to foster development of new and innovative medicines

EU Commision has announced the continuity of the Horizon H2020 projects for the next 2021-2027

July 23, 2018

The new programme, Horizon Europe, is proposing 100 billion for research and innovation.

Medical Device Trainings on European Regulation

July 20, 2018

Impact of the new MD regulatory requirements presented by Asphalion experts

A change that affects every ANDA and 505(b)(2) amendment to an unapproved application

July 12, 2018

Do not let your ANDA amendment to be deficient!

New IRIS portal will be mandatory for Orphan Drug Designations process

July 11, 2018

EMA expects the portal to reduce the time needed to prepare and submit applications

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