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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 eSubmissions · ISO IDMP & 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

EVENTO | FARMAFORUM Taller: “Revisión y sustentación de declaraciones bajo MDR”

October 25, 2021
No os perdáis este taller en el marco del congreso de Farmaforum. Nuestras expertas, Dominique Monferrer, Medical Device Director y Laura García, Medical Device Manager, impartirán una charla práctica sobre la “Revisión y sustentación de declaraciones bajo MDR”.

ASPHALION´S COVID-19 CONTRIBUTION: 17 PROJECTS

October 22, 2021
Coinciding with the end of many restrictions related to the pandemic announced by local authorities this week, we would like to look back and put in perspective and thank our team for their hard work.

 NEW SERVICE | CTIS TRAINING BY ASPHALION

October 21, 2021
We are pleased to introduce our new specific training services for pharma and biotech companies in order to guide them through the correct implementation of the new Clinical Trial Information System (CTIS).