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
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
Filtración Esterilizante y Aspectos Regulatorios – Jueves, 17/9 – Online Training by 3M & Asphalion
Advanced Therapies Congress & Expo 2020
MDR | Guidance documents and updates on clinical investigation and evaluation
Summer – Asphalion does not close in August!
Latest Tweets
#WHITEPAPER | @veevasystems and @Asphalion have joined forces developing a “white paper” that examines the business drivers behind this change. As a result, we have identified 3 critical factors to maximize the benefits of a unified #RIM solution.
🔗https://t.co/Xu4Dmt5xBR
