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
Stay tuned! Subscribe to Asphalion Newsletter
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
Visit Asphalion´s virtual booth at the Global Pharmaceutical Regulatory Affairs Summit 2021 and help the environment!
Webinar | Medical Device Regulation (MDR) impact in Pharma Industry: Article 117
NEW Pharmacovigilance services
Demo room at Asphalion´s virtual booth- Global Pharmaceutical Regulatory Affairs Summit 2021
Latest Tweets
VIRTUAL EVENT | Hard Reg Café: “A multi-faceted view of the ATMPs Regulatory challenges”
📌Do not miss it! @Asphalion expert, Christopher Mann, will be speaker on this online session organized by CataloniaBio & HealthTech.
📆 28 April
🕛 3:00 p.m.
ⓘ👇:
#Regulatory #ATMPs
🟢 Interested to know often-challenging #RegulatoryATMP problems? Last days to register at Hard Reg Café 👉🏼 https://lnkd.in/dkt5vBr
With renowned experts:
- Advisor: @Asphalion
- Clinician: @hospitalclinic @SJDbarcelona_ca
- Company: TETEC (@bbraun_com)
- Regulator: @AEMPSGOB
👉 Online Webinar |Medical Device Regulation (MDR) impact in Pharma Industry: Article 117
Learn about the impact on life-cycle management of integral DDCs that this new regulation will have.
28/4 2 p.m. CET (30’ webinar + 15’ Q&A)
👥@Asphalion MD team
https://bit.ly/2Q7bKoI
