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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

iso idmp

EU ISO IDMP Implementation Guideline – V1

February 13, 2020
Finally, EMA have released version 1 of the EU IDMP Implementation Guideline (EU IG v1).
MAGIC LINE

Asphalion & Magic Line 2020

February 12, 2020
On March 1st Asphalion will join the solidarity march for the Hospital Sant Joan de Déu: La Magic Line.
PV and Reg Services

Pharmacovigilance and Regulatory services in the UK

February 11, 2020
As of 1 February 2020, the United Kingdom (UK) is no longer an EU Member State and acts as a third country. This means that the UK no longer participates in EU institutions and their decision-making.
women in science

Today is the International Day of Women and Girls in Science

February 11, 2020
At Asphalion we work together with our clients to generate ideas and implement solutions that contribute to improve people's quality of life.