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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

MDR corrigendum | Manufacturers of Class I MD may have 4 years more to meet the regulation’s standards

January 13, 2020
UPDATE: The corrigendum for the EU’s Medical Devices Regulation (MDR) granting manufacturers of Class I devices upclassified under MDR a four-year transitional period has been approved and published.
Formatted Letter Template

Formatted Letter Template | No longer maintained by EMA

January 9, 2020
As from January 1st 2020, the Formatted Letter Template used in CP applications is no longer maintained by EMA.

Asphalion team wishes you a Merry Christmas and a Happy New Year

December 19, 2019
2020 is very special for us as we will celebrate the 20th Anniversary of Asphalion. Thank you for being part of it!
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May 2020 | Only a few months remain for DoA of the new MDR

December 4, 2019
May 2020 is round the corner and therefore, only a few months remain for date of application (DoA) of the new medical device regulation (MDR).