Asphalion
Asphalion is an international Regulatory, Scientific & Safety consultancy with offices in Barcelona, Madrid, Pamplona, Munich, and London. Founded in 2000, it has grown steadily, now employing over 200 professionals from more than 16 nationalities. ASPHALION is a key player in the global healthcare sector and a reference in implementing new regulatory standards for Pharmaceutical, Biotech, and MedTech companies. It offers strategic advice, expert consulting, operational support, and full outsourcing for all therapeutic areas. ASPHALION is actively pursuing its digitalization pathway, embracing innovative technologies and data-driven processes to reinforce its position as a leader in regulatory science. To ensure the best solutions, ASPHALION collaborates with international authorities, notified bodies, scientific associations, and key opinion leaders, maintaining a strong network of geographic and functional partners.
Role within GreenNanoBone
Asphalion will provide regulatory support throughout the span of the project, with different tasks including, but not limited to: (i) product classification based on current regulations, (ii) establishment of a pre-clinical plan ensuring according to current regulatory standards. (iii) Communication of regulatory strategy to the consortium, (iii) coordination and execution of assessment meeting with regulatory agencies to ascertain that GreenNanoBone development strategy is aligned with regulatory agencies expectations, (iv) Drafting of an investigational medicinal product dossier for GreenNanoBone.