Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Munich, Amsterdam and London.
Our services
Regulatory and Scientific Strategy during Development
Minimizing time-to-market and maximizing cost efficiency by establishing the right strategy for the product development.
Medical and Scientific Writing
Meticulous and consistent CTD dossier preparation to assure successful registration.
Global Submissions
Assessment of regional requirements based on experience and reliable coordination of local partners for global registration procedures.
eCTD and RIM
Comprehensive eCTD services by using advanced e-tools and efficient Information Management by implementing RIM solutions.
Life-Cycle Outsourcing
Maintenance work support to improve processes and maximize productivity.
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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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, etc.
Latest News
Barcelona Innovation Day/ London 2020
Asphalion receives medal for sustainability from EcoVadis
Webinar | “Introduction to regulatory aspects of IVD medical devices”
Digital Health Panel Discussion 2020 – “Overcoming top challenges in digital health”
Latest Tweets
#H2020 | The EU has awarded a grant of 25.5€ million for the #ARDAT project. The consortium brings together the leading expertise of 34 organizations including @Asphalion, which will provide continuous #regulatorysupport.
👉 More information 👉 https://www.asphalion.com/new-h2020-project-on-atmps-asphalion-is-the-regulatory-partner-of-the-ardat-project/
