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 eSubmissions · ISO IDMP & 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 Tweets
➨ #SINPAIN partners have met this week at the kickoff meeting. @Asphalion carries out the #Regulatory activities of the project, which is game-changing with regards to tackling the pressing need for effective and economical #osteoarthritis treatments.
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