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.
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
Services
Memberships
Quality Management System
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