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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

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

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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

BIO EUROPE 2020

BIO-Europe® Digital 2020

October 19, 2020
BIO-Europe® Digital 2020, the largest life science partnering event worldwide, will take place next week, October 26th-29th. This event will be held digitally and Asphalion will be there!
Barcelona Health Hub

Asphalion joins Barcelona Health Hub to boost technological and digital innovation in the healthcare sector

October 19, 2020
Asphalion has signed an agreement to be part of Barcelona Health Hub (BHH), a non-profit organization oriented to the development of companies and organizations working in the field of digital health in order to enhance innovation.
Advanced FDA Regulatory Affairs

Register now for the Advanced FDA Regulatory Affairs online training course by LS Academy!

October 15, 2020
This online training course will take place on the 4th and 5th of November, 2020 and it will provide you with an insight into the required information on how to set up your product development and successfully get an FDA registration approval.
Nitrosamines Risk Assessment

Nitrosamines Risk Assessment – Deadlines & Updates

October 14, 2020
Updates that allow pharmaceutical companies from now on to define a common strategy for the Nitrosamines Risk Assessment process.