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

Our services

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Regulatory and Scientific Strategy during Development

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

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Medical and Scientific Writing

Meticulous and consistent CTD dossier preparation to assure successful registration.

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Global Submissions

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

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eCTD and RIM

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

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Life-Cycle Outsourcing

Support for maintenance work to improve processes and maximize productivity.

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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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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

Asphalion Open Doors was amazing!

June 14, 2019
The first edition of Asphalion Open Doors took place last 7th June in Barcelona!
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SME Office – Annual Report 2018

June 12, 2019
he SME Office has published its annual report summarising its experience with small and medium-sized enterprises (SMEs) during the year 2018.
WEBINAR PV

Bases de datos de Farmacovigilancia: ¿qué debe saber IT?

June 11, 2019
Si necesitas saber qué tipos de bases de datos existen para Farmacovigilancia y cómo garantizar las seguridad, integridad y trazabilidad de los datos, no pierdas nuestro próximo webinar que tendrá lugar el día 28 de Junio de 11-12 horas. 
LS ACADEMY PV

Are you ready to enter the transformed landscape in Pharmacovigilance?

June 6, 2019
On 12 & 13 June, Sónia Lopez, Qualified Person Responsible for Pharmacovigilance at Asphalion, and Núria Cabello, Senior Drug Safety Officer at Asphalion, will be participating in the International Pharmacovigilance Day conference organized by LS Academy.