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

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

Filtración Esterilizante

Filtración Esterilizante y Aspectos Regulatorios – Jueves, 17/9 – Online Training by 3M & Asphalion

September 14, 2020
El próximo 17 de septiembre de 10h a 13h, 3M y Asphalion se unen en la I Sesión Formativa Online "Filtración Esterilizante y Aspectos Regulatorios" para contaros las estrategias y claves de éxito para vuestros procesos.
Advanced Therapies Congress

Advanced Therapies Congress & Expo 2020

August 27, 2020
Asphalion will be participating in the Advanced Therapies Congress & Expo 2020.

MDR | Guidance documents and updates on clinical investigation and evaluation

August 13, 2020
Although the date of application of the MDR has been postponed, on 26 May 2021 the Regulation will become fully applicable, following the transition period.
Asphalion - summer time 2020

Summer – Asphalion does not close in August!

July 31, 2020
We will be open in August and available to attend all your needs and requests as usual!