ASPHALION is an international Regulatory, Scientific & Safety consultancy company with offices in Barcelona, Madrid, Munich and London.
Its strong track record has made ASPHALION a reference in the international healthcare sector and a key stakeholder in the implementation of new regulatory standards, covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices.
ASPHALION offers strategic advice, expert consulting, operational support, as well as full outsourcing services for all types of products in all therapeutic areas.
To deliver the best possible solution in each project, ASPHALION works closely with international competent authorities, notified bodies, scientific associations and key opinion leaders and maintains a comprehensive network of geographic and functional partners.
Asphalion will lead the regulatory activities of the EChiLiBRiST project.
To this purpose, Asphalion will accompany the consortium in the elaboration of a strategic regulatory roadmap that will facilitate the future CE-marking, allowing its future use in real-world clinical settings.