Asphalion’s commitment to ethical development and use of Artificial Intelligence

December 11, 2023

Asphalion’s mission is to work jointly with pharma, biotech and MedTech companies to generate ideas and implement solutions that contribute to improving health in all our lives.

We believe that Artificial Intelligence (AI) will provide significant acceleration and improvement of many aspects in regulatory affairs and vigilance. Nevertheless, we also strongly believe that all AI advances must follow a human-centric approach and that the quality and ethical soundness of our work shall not be compromised by the use of AI/machine learning technologies.

Have a look at Asphalion’s AI Ethics Principles:

  1. Human Agency and Oversight: Our AI-based solutions will be supportive tools, complementing and not replacing human decision making in critical areas. Final decisions and Quality Control will be made by trained professionals, with AI providing data-driven recommendations.
  2. Legal Compliance: We will only develop and use AI systems that comply with applicable laws and regulations, including guidelines established by agencies such as the EMA or FDA.
  3. Social Welfare: We are committed to developing and using AI solutions with the primary objective of improving health in all our lives by ensuring access to safe and effective medicines.
  4. Privacy and Security: We are committed to protecting data privacy and security by implementing robust cybersecurity measures and complying with data protection regulations. We recognize that health data is extremely sensitive and ensure its maximum protection, complying with regulations such as GDPR and other privacy standards.
  5. Technical Robustness and Security: We will only use AI solutions that have been rigorously tested prior to deployment in production environments. We will strive to ensure that AI systems are robust and safe, avoiding errors that could affect public health.
  6. Education and Training: We will encourage ongoing AI training for our staff and partners, ensuring that they are informed about their ethical challenges and how to address them.
  7. Collaboration: We will actively seek cross-sector collaborations to share knowledge, best practices and address ethical challenges together. We will closely monitor policies of organizations and governments around the world to establish a global and coherent approach to the ethics and use of AI.
  8. Responsible Innovation: We will innovate responsibly, considering the ethical, social and economic implications of AI solutions.
  9. Ongoing Review: We will establish mechanisms to periodically review and update this ethical commitment, adapting to changes and advances in the field of AI and pharma, biotech and MedTech regulation.


This ethical commitment reflects our dedication to using Artificial Intelligence in a responsible and ethical manner in the pharma, biotech and MedTech sector, ensuring that the solutions we develop and apply are beneficial to society as a whole.

Search News & Events

  • Filter by category


Related news and events

Pamplona office | Talent pool

Join Our Pamplona Team! Are you in Pamplona and passionate about Regulatory Affairs & Safety? Asphalion is expanding and looking for talented professionals! About Us:

ASPHALION | Social media

Stay informed with Asphalion’s latest regulatory updates by following our social media pages and be the first one to find out about regulatory news, webinars,

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting