Asphalion

ASPHALION is an international Regulatory, Scientific & Safety consultancy company with offices in Barcelona, Madrid, Munich, London, and Pamplona. Since its foundation in 2000, ASPHALION has grown consistently to employ over 190 professionals representing more than 16 nationalities. Its strong track record has established ASPHALION as a key player in the international healthcare sector and a major contributor to the implementation of new regulatory standards.
ASPHALION provides expert consulting, strategic advice, operational support, and full outsourcing services for all product life cycle stages across all therapeutic areas. Its team offers tailored solutions for Pharmaceutical, Biotechnological, and Medical Technology companies, having successfully delivered over 5,000 projects for more than 1,000 clients from over 50 countries. Services span non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions, and data management for both medicinal products and medical devices.
The company’s expertise is particularly notable in the field of Advanced Therapy Medicinal Products (ATMPs), where their team possesses specialized scientific knowledge and extensive regulatory experience. ATMPs require unique development strategies and regulatory adaptations due to their complexity. ASPHALION provides comprehensive support, including drafting regulatory, non-clinical, clinical, and CMC documentation essential for development, registration, and lifecycle management. Additionally, they offer strategic guidance on segmentation, niche indications, conditional approvals, fast-track processes, orphan drug designations, and preclinical and clinical development plans to minimize time-to-market.
ASPHALION has been a leader in ATMP regulatory support since 2005, participating in over 30 projects covering 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), and more). By collaborating closely with international competent authorities, notified bodies, scientific associations, and key opinion leaders, ASPHALION ensures the delivery of optimal solutions for every project. Their comprehensive network of geographic and functional partners further solidifies their ability to meet the needs of a dynamic and evolving healthcare landscape.