Asphalion is an international Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid and Munich. We collaborate with Pharma and Biotech companies facilitating Drug Development and Regulatory Affairs projects for Drugs, Biologics, Biosimilars, ATMPs and Medical Devices. Our involvement ranges from early development, through to registration and post-commercialization phases. Since the company was founded in 2000, we have consistently grown and now have a team of over 80 employees with backgrounds in all areas of life sciences. Our consultants are experts in their fields and are in direct contact with European agencies for the implementation of new regulatory standards. We provide global services and work for hundreds of clients from around the world. Through collaborations with partners in all other continents, we can accelerate your worldwide scientific and regulatory activities by using local expertise.
• Regulatory and Scientific Strategy during Development
• Medical and Scientific Writing
• Global Submissions
• eSubmission and RIM
• Life-Cycle Outsourcing
• Promoting the marketing registration of Medical Devices: Classification strategy, CE Marking and compilation of technical file.