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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

ASPHALION | eSub360 Services

July 22, 2021
At ASPHALION we can help you with outsourcing of “publishing” solutions every time of the year, but we understand summer is a time where many unforeseen events could happen.

ASPHALION LISTED TOP PHARMACOVIGILANCE SOLUTIONS PROVIDER IN EUROPE 2021 | INTERVIEW WITH OUR CEO

July 21, 2021
As we announced last week, ASPHALION has been listed as “TOP PHARMACOVIGILANCE SOLUTIONS PROVIDER in EUROPE 2021” by Pharma Tech Outlook.

HORIZON CALL | OPENING

July 20, 2021
From ASPHALION, we would like to inform you of the opening of the call:HORIZON-HLTH-2021-DISEASE-04-02: Building a European innovation platform for the repurposing of medicinal products

MEET THE TEAM | RICARD ANDREU, SCIENTIFIC AND REGULATORY AFFAIRS OFFICER

July 20, 2021
Do not miss this video! Have a look at Ricard Andreu talking about how thanks to a nine-month internship at ASPHALION, he landed his current job as Scientific and Regulatory Affairs Officer.