News in Medical Devices

January 23, 2019

Upclassification of substance-based Medical Devices under MDR 2017/745

New office in Barcelona

January 18, 2019

Asphalion is starting a very special 2019 and we want to share this special moment with all of you.

The Lapse in Funding affects activities of FDA

January 11, 2019

During the lapse period, the agency will be continuing only vital activities, to the extent permitted by the law, that are critical to ensuring public health and safety in the United States.

Centralised Procedures News – Delay!

January 10, 2019

From 1st February 2019, the Formatted Letter Template for Centralised Procedures will no longer be needed. – DELAY!

Save the date: 31.January -1.February 18th Regulatory and Scientific Affairs Conference

January 8, 2019

If you are interested in starting the year by getting fully informed about the activities and future plans in Regulatory in Europe, Medicines for Europe´s conference is the best place.

MHRA: if there’s no Brexit deal

January 7, 2019

To start the year, MHRA has published a statement on 3rd January in case of a no deal scenario between UK and EU.

Merry Christmas and a Happy New Year

December 19, 2018

Asphalion team wishes you a Merry Christmas and a Happy New Year, filled with happiness and success!

Revised EDQM guideline on requirements for revision/renewal of CEPs

December 14, 2018

In January 2019, the revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ will enter into force.

Are you looking for a Horizon 2020 regulatory partner?

December 12, 2018

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

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

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