ASPHALION is an international Regulatory, Scientific & Safety consultancy company with offices in Barcelona, Madrid, Munich and London. Founded in 2000, ASPHALION has grown consistently and currently employs over 170 team members of over 16 different nationalities.
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. ASPHALION’s experts have delivered solutions to over 1,000 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50 countries in over 5,000 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 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.
Role in METHYLOMIC project
Asphalion will be in charge of the Regulatory pathway throughout the project and during the kick-off presented the tasks that shall be performing and the regulatory challenges that lie ahead:
- Regulatory Roadmap
- Regulatory Plans (Design and Development, Risk Management, Usability and Software Validation)
- Quality Control support
- Contact with regulatory bodies and Notified Bodies
- Support during IVD Performance Studies and Performance Study submission