Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Munich and Amsterdam.
Our services
Regulatory and Scientific Strategy during Development
Minimize time-to-market and maximize 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
Support for maintenance work to improve processes and maximize productivity.
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
Q&A document on the implementation of the MDR and IVDR
Graphene Connect on MedTech and Diagnostic Technologies
Brexit | Very interesting and productive day!
La Castanyada & Halloween in Asphalion
Latest Tweets
Oriol Penon, Business Development Manager at ASPHALION, is attending #BIOEuropeAutumn in Hamburg.
If you're participating in this #conference and want to meet us, please send an email to [email protected]
#bioeurope #Asphalion
More information: https://t.co/ZlZSlxgbkk
