Expert Guidance for Global Medical Regulations

Based in Denmark, SAXOCON is a consulting company helping businesses in the medical industry test, document, and certify that their products comply with relevant regulations and guidelines in the EU and beyond. Our specialists are experts in toxicology, materials science, supply chain management, and quality management systems, with a deep understanding of science and technology, the intricacies of the regulatory process, and how best to work with regulatory bodies around the world.

Furthermore, we directly contribute to the development of global standards through our participation in the ISO 10993-17 working groups. In addition to traditional toxicological assessment methods, we are also experts in in-silico risk assessments using QSAR and read-across-based evaluation methods. Whether you produce medical devices, pharmaceuticals,  raw materials, chemicals, food products, or cosmetics, we offer services that help you better understand the risks involved with your products and get them to market in a safe and timely manner.

History

SAXOCON was founded in October 2013 when entrepreneur Martin Friis-Mikkelsen and the Technical University of Denmark (DTU) joined forces.

In early 2013, the QSAR team from DTU Food was looking for the right entrepreneur to bring their cutting-edge technology and unparalleled expertise in QSAR data analysis and interpretation to the commercial market. This data had, for several years, been used exclusively by public authorities across Europe. When Martin and the QSAR team agreed to create SAXOCON, they brought the benefits of this technology and expertise to the commercial market.

Since 2013, SAXOCON has expanded its portfolio of toxicological testing and risk assessment to the medical device, raw materials, pharmaceutical products, food ingredients, chemical, and biocide industries.

DTU Co-ownership

SAXOCON is ISO 13485:2016 certified and co-owned by the Technical University of Denmark (DTU). This partnership gives SAXOCON’s toxicologists access to their outstanding research facilities at the National Food Institute. This arrangement secures reliability in delivery, continuous product development, and access to the latest research. It also connects private industry to knowledge previously only available to research institutions and the public sector.

Mission & Vision

• Mission:
  SAXOCON aims to help the medical sector create safe, reliable products for their customers through state-of-the-art toxicological risk assessment and extensive, up-to-date regulatory knowledge.
• Vision:
  SAXOCON aspires to be the standard-bearer and agenda setter for the future of toxicological risk assessment. We are also leaders in using and developing cutting-edge tools and knowledge in the toxicological consulting industry.

Values

We believe that being the best and most reliable toxicology partner for our clients rests on a foundation of honesty. Our customers need to be able to trust our advice intrinsically. We must be absolutely credible in order to guide them through the testing and assessments necessary to have their products certified. Only through uncompromising integrity and honesty can we become a preferred partner for our customers.

From initial contact through to the submission of a final analysis, we strive to ensure an open dialogue between us and our clients, tightly aligning expectations that allow for the delivery of high-quality products that meet client needs.

As a workplace, SAXOCON’s values are:

• Honesty: Everything we do is rooted in integrity.
• Teamwork: We are strongest when we work together as a team.
• Respect: We foster understanding and empathy for each other and our differences.
• Openness: All questions are welcome and met with an open mind.
• Professionalism: We are passionate experts who take pride in delivering high-quality work.