Asphalion SL (ASP)
Asphalion S.L. (ASP) is an international Drug Development and Regulatory Affairs Consultancy based in Barcelona and Munich with over 1,800 accumulated projects, and activities in over 50 countries. ASP is equipped with most updated e-submission tools, adapted to the new directive in pharmacovigilance, has vast experience in world-wide regulatory strategy while working in biotech since 2000 and advanced therapies since 2005. Founded in 2000, ASP has consistently grown for over 15 years and now consists of over 60 professional consultants with backgrounds in Pharmacy, Chemistry, Biology, Pharmacology and Biotechnology.
Within MYOCURE, ASP will be responsible for regulatory strategy, briefing package for scientific advice, regulatory support during non-clinical phase, certification, compilation of IMPD, IB, and CTA for Phase I and IIa studies, contacts with NCA and CEICs, reports production and review. ASP will contribute their in-depth expertise in Advanced Therapy Medicinal Products. The partner’s remarkable experience in innovative products, therapeutic vaccines, biological and biotechnological products, and advanced therapies including gene-therapy (AAV-vectors) and autologous cell-therapy will be a particular asset to the MYOCURE project.