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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

COVID-19 | AEMPS will carry out remote inspections of Good Practice in Pharmacovigilance

June 4, 2020
The AEMPS announced last week that in order to allow the normal activity of MAHs and to be able to supervise it adequately, the GCP and GMP inspection area will carry out remote pharmacovigilance inspections whenever possible.

COVID-19 | EMA decided to extend the MLM Service

June 2, 2020
The European Medicines Agency (EMA) decided to extend the Medical Literature Monitoring (MLM) service to cover substances used in products of interest in the COVID-19 context.
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Updated version of the document “EMA post-authorisation procedural advice for users of the centralised procedure”

May 29, 2020
Last week, European Medicines Agency (EMA) updated the guidance document “European Medicines Agency post-authorisation procedural advice for users of the centralised procedure".
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New regulation to ease the renewal of the designation of NBs and prevent shortages of MDs in the EU

May 27, 2020
The European Commission (EC) has published a Commission Implementing Regulation to ease the renewal of the designation of notified bodies (NBs) and prevent shortages of medical devices (MDs) in the European Union (EU).