Asphalion & Asphalion MedTech
Asphalion is an international scientific and regulatory consulting company with more than 25 years of experience supporting the life sciences industry. We provide strategic, regulatory, scientific, and compliance services to pharmaceutical, biotechnology, ATMP, veterinary, and medical device companies throughout the entire product lifecycle — from early development to post-marketing.
Our expertise includes regulatory strategy and submissions (EMA and global markets), clinical and CMC support, pharmacovigilance, regulatory intelligence, lifecycle management, and compliance. We help companies obtain and maintain marketing authorisations while ensuring alignment with evolving European and international regulations. Asphalion operates under certified quality and information security management systems (ISO 9001 and ISO 27001), ensuring high standards of quality, reliability, and data protection.
Asphalion MedTech, our specialised medical device division, supports manufacturers of medical devices and IVDs with MDR/IVDR compliance, CE marking, clinical and performance evaluation, post-market surveillance, and technical documentation. A key pillar of our support is the implementation, optimisation, and maintenance of ISO 13485-compliant quality management systems, ensuring robust regulatory compliance, efficient processes, successful Notified Body interactions, and long-term market sustainability under the MDR/IVDR framework.
We are strongly committed to digitalisation and innovation in regulatory science, actively exploring digital tools and AI-driven solutions to optimise regulatory processes, enhance data analysis, and support compliance. We are particularly interested in the regulatory framework surrounding AI, digital health, and data governance in the EU.
What are we looking for?
As new members of EUROPHARM SMC, we look forward to actively contributing to working groups, sharing regulatory expertise, engaging in industry discussions, building partnerships, and participating in events, while supporting members in their regulatory and digital transformation challenges.
How to contact us?
We will be very pleased to meeting you at the Europharm International Business Meeting in Berlin on the 16th & 17th of April 2026 : www.europharmbusinessmeeting.com
LIDIA CÁNOVAS MÉNDEZ
Key Accounts Director
T +34 932 385 945
more: www.asphalion.com