ASPHALION is an international Regulatory and Scientific Consulting in Life Sciences, delivering solutions to over one thousand Pharmaceutical, Biotechnological and Medical Technology companies from more than fifty countries in over five thousand projects since its foundation in 2000.
ASPHALION offers strategic advice, expert consulting, operational support, and full outsourcing services for all types of products in every therapeutic area. These areas include covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for pharma, biopharma and medical devices clients.
Role within SINPAIN
Asphalion is the regulatory partner of the project and the leader of Work Package 6 (WP6). Asphalion will guide all partners and assure the compliance of the regulatory requirements for the development of the nanotherapeutics. To ensure the translation of the proposed idea, a detailed regulatory roadmap was established at the start of the project and will be validated with the Innovation Task Force (ITF) of the EMA. The clinical development of the nanotherapeutics and CMC aspects would be also considered from the regulatory perspective. Finally, an ATMP classification request will be envisaged to have a clear regulatory definition of the nanotherapeutic product. During the project Asphalion also will organize a regulatory workshop with all Intellectual Property (IP) and partners in order to engage them in the regulatory field.