ASPHALION is an International Drug Development and Regulatory Affairs Consultancy based in Barcelona with over 1800 accumulated projects and activity in over 50 countries. Since 2000, the company have consistently grown and now have almost 100 professional consultants with backgrounds in Life sciences (Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Medicine and Veterinary Medicine). ASPHALION counts with wide expertise in regulatory advice during drug development including:
- Regulatory expertise in Cell and gene therapy products, and other innovative medicinal products,
- High number of Scientific Advice meetings as well as presubmission meetings with National competent authorities (NCAs) as well as European medicines agency (EMA) and the Food and Drug administration (US FDA).
- Vast and extensive regulatory strategy consultants and support in CMC, preclinical and clinical during drug development.
- IMPD and IB compilation for Clinical Trials Application (CTA) submissions.
Role within SBR
The main role of ASPHALION within SBR is to be the regulatory partner holding the expertise in the regenerative medicine field. They will give scientific and regulatory inputs as well as technical advice to comply with current legislation and guidelines. ASPHALION will also conduct regulatory meeting advice with the EMA.