Asphalion S.L. (ASPH)

Our institution

Asphalion is an international Scientific and Regulatory Affairs consultancy company with offices in Barcelona, Madrid, Munich and London. Asphalion is a reference in the international healthcare sector and a key stakeholder in the implementation of new regulatory standards. Asphalion’s experts have delivered solutions to over 900 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50 countries in over 4,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices. Asphalion works closely with international competent authorities, notified bodies, scientific associations and key opinion leaders to offer strategic advice, expert consulting, operational support, as well as full outsourcing services for all types of products in all therapeutic areas.

Our role in NABIHEAL

Asphalion will be responsible of the Regulatory aspects and Ethics of the project (WP6). Regulatory requirements will be implemented by providing appropriate inputs to any of the WP of the project, as well as by consultation with EU regulatory authorities to get valuable inputs that validate or complement the development plan. Asphalion activities within the project include the elaboration of a Regulatory Roadmap, a regulatory workshop, consultancy with Regulatory authorities (ITF or Scientific Advice), the outline of clinical development and the continuous assessment of regulatory issues.