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

Our services

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

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The new General Data Protection Regulation (GDPR) came into effect on May 25th 2018. For this reason, if you are interested in receiving our communications regarding publications, news and invitations to events, we need your approval in order for Asphalion to process your personal data and be able to send you these communications.

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Latest News

Asphalion and Agatha New Partnership

Asphalion and Agatha New Partnership

March 20, 2019
We are delighted and proud to announce that Asphalion signed a reselling partnership agreement with Agatha Inc., a global leading provider of Quality and Content Management cloud service.

Asphalion, partners hacia el futuro

March 19, 2019
Asphalion, partners hacia el futuro es un programa gratuito dirigido a los departamentos de IT donde nuestros expertos comparten conocimiento y aportan soluciones a los retos diarios.

10th anniversary of Andalusian Advanced Therapies Initiative

March 19, 2019
From Asphalion we want to congratulate the Andalusian Advanced Therapies Initiative for its 10th Anniversary and its excellent work.

From 4 to 8 March, the Agency is operating remotely.

March 6, 2019
From 4 to 8 March, the Agency is operating remotely. From 11 to 15 March, EMA staff will gradually move into a temporary building in Amsterdam, called the Spark building.