Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Munich and Amsterdam.

Our services

development

Regulatory and Scientific Strategy during Development

Minimize time-to-market and maximize cost efficiency by establishing the right strategy for the product development.

Medical and Scientific Writing

Meticulous and consistent CTD dossier preparation to assure successful registration.

Global Submissions

Assessment of regional requirements based on experience and reliable coordination of local partners for global registration procedures.

eCTD and RIM

Comprehensive eCTD services by using advanced e-tools and efficient Information Management by implementing RIM solutions.

Life-Cycle Outsourcing

Support for maintenance work to improve processes and maximize productivity.

Pharmacovigilance

Handling Case Management and implementation of reporting tool. Support to set up a Quality system though PV system audits and QPPV services.

Specialists in:
Drugs  –  Biologics  –  ATMPs  –  Medical Devices

ASPHANEWS_2

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Latest news, tips, advice and fresh perspectives on Regulatory Affairs including: deadlines, updates, FDA, EMA, innovative solutions, Brexit, eSubmissions, drug development, guidelines, ODD, strategic consulting, scientific, procedures, roadmaps, …

Latest News

sant jordi

Sant Jordi’s Day

April 23, 2019
Saint Jordi's Day is one of the most original celebrations in Catalonia and takes place on 23 April.  This popular festival combines culture and romanticism. On this day, it is custom for couples to exchange gifts...
ehdn meeting

Invasive Therapies Meeting by EHDN Invasive Therapies Working Group

April 17, 2019
Next week, our Scientific & Regulatory Affairs Associate Director Christopher Mann will be participating in the Invasive Therapies Meeting organised by European Huntington's Disease Network (EHDN) Invasive Therapies Working Group, in collaboration with SCHD (Stem cells for HD).
cart t-cell therapy

CAR T-cell therapy

April 16, 2019
Are you working in CAR T therapies, advanced therapies or personalised medicine and would like additional regulatory support? Please contact Asphalion at [email protected]
brexit

Brexit: Article 50 extension

April 15, 2019
On 5 April, Theresa May asked EU for Brexit extension and on 11 April, the EU agreed to a further extension of the date for the UK’s withdrawal from the EU. The extension will last as long as necessary and, in any event, no longer than 31 October 2019.