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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

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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

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Asphalion’s LinkedIn community now has 10,000 followers!

July 16, 2019
Asphalion’s LinkedIn community now has 10,000 followers! Today, we are celebrating reaching this milestone by having a special breakfast with all of Asphalion’s employees.
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New QRD template released on EMA website

July 11, 2019
At the end of June 2019 EMA published new QRD template (v10.1) for centrally authorized products.
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DMFs in Health-Canada

July 10, 2019
From 1st September 2019, all new Master Files submitted to Health-Canada must be in eCTD format, in addition, when converting MFs from non-eCTD format to the eCTD format, the entire MF must be provided in the first eCTD transaction, as a baseline requirement.
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Spanish Notified Body 0318 Applies for EU MDR Redesignation

July 9, 2019
Last week, the Spanish Agency of Medicines and Medical Products (AEMPS) announced it’s notified body (NB) 0318 has begun the process to become designated as NB under the European Union’s medical device regulation (MDR).