Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Munich and Amsterdam.

Our services

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Regulatory and Scientific Strategy during Development

Minimize time-to-market and maximize 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

Support for maintenance work to improve processes and maximize productivity.

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Pharmacovigilance

Handling Case Management and implementation of reporting tool. Support to set up a Quality system though PV system audits and QPPV services.

Specialists in:
Drugs  –  Biologics  –  ATMPs  –  Medical Devices

ASPHANEWS

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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, …

Latest News

gene therapy

Gene therapy for SCID-X1

May 20, 2019
A new gene therapy study in New England Journal of Medicine reports positively on the use of a self-inactivated  lentivirus supplemented by an insulator and a codon-optimised human common γ chain gene to treat SCID-X1 disease.
new ley

EU measures in support of generic pharmaceuticals producers

May 17, 2019
The EU adopts regulation to promote the competitiveness of EU producers of generic medicines and biosimilar products.
oriol and christopher

Are you attending the 14th #WATRMC in London?

May 16, 2019
Are you attending the 14th World Advanced Therapies & Regenerative Medicine Congress in London? Take a moment to visit Asphalion at booth 43.
asphalion team

Asphalion is companionship

May 15, 2019
Asphalion is passion, flexibility, quality, commitment…but above all, Asphalion is companionship. Last week, the Asphalion’s annual team building took place in Barcelona.