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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

Minimizing time-to-market and maximizing 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

Maintenance work support to improve processes and maximize productivity.

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Pharmacovigilance

Case Management handling and implementing reporting tool. Providing support to set up a Quality system through 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, etc.

Latest News

WORLD HEPATITIS DAY

July 28, 2021
Today, on World Hepatitis Day, the world comes together to raise awareness of hepatitis, one of the most deadly and neglected diseases and health crises.

HORIZON CALL | OPENING

July 28, 2021
From ASPHALION, we would like to inform you of the opening of the call:HORIZON-HLTH-2021-DISEASE-04-07: Personalised medicine and infectious diseases: understanding the individual host response to viruses (e.g., SARS-CoV-2)

ASPHALION MANAGEMENT SERVICES | Substances, Products, Organisations, Referentials (SPOR)

July 27, 2021
Do you have all your organisation information up to date in SPOR? EMA has recently communicated that the use of Organisation Management Service (OMS) in the eAF for CAP will be mandatory.

ASPHALION | EXPERTISE IN EUROPEAN PROJECTS

July 27, 2021
At ASPHALION, we have experience as Regulatory Partners in more than 14 European granted projects, providing Regulatory Affairs support throughout the whole project duration.