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Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Amsterdam and Munich. Asphalion provides a global range of services, for global clients.
We offer comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies.
Since 2000, we have consistently grown and now have almost 100 professional consultants with backgrounds in Life sciences (Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Medicine and Veterinary Medicine).
Our consultants are experts in their field and are in direct contact with EU agencies (EMA and NCAs) for the development and implementation of new regulatory standards. Our services range from early development, throughout the registration, until marketing and post-commercialization phases of your product.
Through our network of regulatory consultants, Asphalion is in a position to support your worldwide scientific & regulatory activities. We make use of a dedicated US agent in the fields of Pharma/Biotech, Medical Devices and In Vitro Diagnostics.
Our services include:
- Regulatory and Scientific Strategy during Development
- Medical and Scientific Writing
- Global Submissions
- eSubmissions: eCTD and NeeS
- ISO IDMP and RIM
- Life-Cycle Outsourcing
- CMC Solutions
- ATMPd and Biologics
- Medical Devices
- Drug Development Project Start-Up & Planning
- Pharmaceutical Business Development
Why choose Asphalion:
- Rely on decades of industry experience of our consultants
- Receive fast and independent expert opinions
- Speed-up your work and save time/money
- Add value to your projects
- Validate your development and regulatory strategy
- Take advantage of our international team and its extensive partner network
- Rely on fixed working teams and constant contact persons
- Count on ad-hoc support
- Trust in our maximum flexibility
- Optimise workflows and minimise efforts for maintenance of registered products
- Succeed with complex registration procedures
- Discover professional and reliable service at its best