We have broad experience dealing with ATMPs and Biologics giving strategic regulatory and scientific advice in preclinical, clinical or CMC aspects from early development to clinical stages and marketing authorization procedures. We have experience in different ATMP products such as CAR-T cells, autologous and allogenic expanded stem cells, mesenchymal stem cells, oncolytic virus, AAV, plasmids, among others. Our consultants are experts in their field and are in direct contact with FDA and EU agencies (EMA and NCAs) for the development and implementation of new regulatory standards.
Our activities include preparation of documentation for approval of a clinical trial (IMPD and IND); managing communications with Health Authorities (FDA, EMA, NCA) including Scientific Advice/preIND meetings; preparation of ODD applications; assistance for the application of Fast Track, PRIME or other accelerated assessments; preparation of eCTD dossiers for MA approval; etc.
If you are interested, it would be our pleasure to e-meet you and discuss potential collaboration scenarios.
quality of the Regulatory and Scientific services that Asphalion provides to a large number of international and national clients.
