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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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Stay tuned! Subscribe to Asphalion Newsletter

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

EVENT | READY FOR GROWTH

December 3, 2021
The objective of the event was giving an insight on key aspects of the entrepreneurship process within the healthcare sector.

ASPHALION | eSub360 Services

December 1, 2021
At ASPHALION we can help you with outsourcing of “publishing” solutions every time of the year, but with only a month left to wrap 2021, many unforeseen events could happen.

AWARENESS| WORLD AIDS DAY

December 1, 2021
Today is World AIDS Day, an opportunity to unite in the fight against HIV/AIDS, to show support for those who have been diagnosed and to remember those who have been lost to the disease.

ASPHALION REGTALK | RIMS SERIES

November 29, 2021
We would like to get you acquainted with the Regulatory Information Management Systems (RIMS). The expert Udo Griem, Head of eBusiness Solutions at Körber Pharma Software and Lidia Cánovas, General Manager, Regulatory Affairs at ASPHALION will provide you with an overview about their expertise in RIMS.