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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

Visit Asphalion´s virtual booth at the Global Pharmaceutical Regulatory Affairs Summit 2021 and help the environment!

April 19, 2021
The Global Pharmaceutical Regulatory Affairs Summit 2021 (GPRAS) will take place virtually, starting tomorrow until the 22nd of April and Asphalion will be there!

Webinar | Medical Device Regulation (MDR) impact in Pharma Industry: Article 117

April 19, 2021
Starting on May 26th 2021, integrally-combined DDCs will fall under Article 117 of the MDR.

NEW Pharmacovigilance services

April 16, 2021
NEW Pharmacovigilance services at Asphalion.

Demo room at Asphalion´s virtual booth- Global Pharmaceutical Regulatory Affairs Summit 2021

April 16, 2021
Demo room at Asphalion´s virtual booth- Global Pharmaceutical Regulatory Affairs Summit 2021