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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

Minimizing time-to-market and maximizing 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 eSubmissions · ISO IDMP & RIM

Comprehensive eCTD services by using advanced e-tools and efficient Information Management by implementing RIM solutions.

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Life-Cycle Outsourcing

Maintenance work support to improve processes and maximize productivity.

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Pharmacovigilance

Case Management handling and implementing reporting tool. Providing support to set up a Quality system through PV system audits and QPPV services.

Specialists in:
Drugs  –  Biologics  –  ATMPs  –  Medical Devices

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