ASPHALION´S HIGHLIGHTS | Second quarter 2024
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Asphalion’s team has specific expertise and broad scientific background in regulatory strategy, CMC and clinical development in ATMPs.
ATMPs complexity requires specific development approaches and regulatory adaptations to overcome the challenging environment involving ATMPs.
Asphalion can elaborate all regulatory, non-clinical, clinical and CMC documentation required during development, registration and lifecycle of ATMPs. In addition, strategic inputs can be given from the very beginning for segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical development plans with minimum time-to-market.
ATMPs Solutions
Advanced Therapy Medicinal Product (ATMP) specific services
Regulatory Roadmaps
Scientific Advice
Orphan Drugs Designation (ODD)
Support in Clinical Trial Application in EU (preparation and submission)
Regulatory Tools
Paediatric Investigation Plan (PIP) and Pediatric Study Plans (PSPs)
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Why Asphalion?
First MAA for an ATMP in Europe prepared by Asphalion (2005)
Involvement in several Horizon Europe projects with key ATMP investigators and active participation in societies and meetings. Solid network of partners, CMOs and CROs supporting ATMP development
Several years’ experience providing ad hoc regulatory support and project management for several biotech companies and startups working in the ATMPs field
Strong track record in ATMP projects since 2005 providing regulatory support in more than 30 projects including cell therapy (Autologous and allogenic derived stem cells, CAR-T) and gene therapy (Oncolytic viruses, Adeno-associated virus (AAV), Modified Vaccinia Virus (MVA), Plasmids, Lentivirus, Adenovirus (AdV), etc.).
Main benefits
Related Resources
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Asphalion contributions to the fight against COVID-19
Scientific & Regulatory Affairs Support during development of ATMPs & Biologics
ASPHALION es una empresa internacional líder en Consultoría Regulatoria, Científica y de Seguridad en Ciencias de la Vida. Apoyamos a las empresas en el desarrollo y autorización de medicamentos, desde
A new year, new classes, and a deep dive into advanced therapies, including discussions on the ARDAT project, as part of the University of Sheffield’s Advanced Cell and Gene Therapies
ASPHALION és una empresa internacional líder en Consultoria Regulatòria, Científica i de Ciències de la Vida amb 25 anys a l’avantguarda en matèria reguladora. Donem suport a les empreses en
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