Quality & Compliance
ISO 13485 Certified Toxicology & Regulatory Consultancy
In a highly regulated landscape, the quality of your data isn’t just a preference, it’s a prerequisite for market access. SAXOCON is uniquely positioned as one of the industry’s only specialized consultancies with a Quality Management System (QMS) certified to ISO 13485:2016 (BSI Certificate MD725842).
We Don’t Just Advise on Standards; We Help Design Them
Our commitment to quality extends beyond compliance into active leadership within the regulatory community. SAXOCON’s Chief Toxicologist is a distinguished member of ISO/TC 194, the technical committee responsible for the development and maintenance of the ISO 10993 series.
This direct involvement in drafting the international standards that govern biological evaluation gives our clients a unique advantage:
- Forecasting Changes: We provide early insights into evolving requirements before they are officially published, allowing you to future-proof your product development.
- Expert Interpretation: Our assessments are guided by the true intent behind the standards, ensuring a smoother dialogue with Notified Bodies.
- Global Authority: We apply the same scientific rigor used to draft global regulations to your specific toxicological risk assessments and materials characterizations.
Why Our Certification Matters for Your Business
For our partners in the medical device, pharmaceutical, and chemical sectors, our ISO 13485 certification provides documentation integrity and process transparency that standard consultancies cannot match.
- Seamless Regulatory Integration: Our QMS aligns directly with the requirements of Notified Bodies, streamlining your biological safety and toxicological risk assessments.
- GLP Compliance: We operate in strict accordance with OECD Principles of Good Laboratory Practice (GLP), ensuring that our data is robust, reproducible, and ready for submission.
- Quality by Design (QbD): We view quality as a structural element, not a final check. By integrating quality at the planning stage of every OEL/OEB study or materials assessment, we eliminate compliance bottlenecks before they occur.
Expertise Across Regulated Industries
Our multidisciplinary teams translate complex regulatory environments into actionable strategies for:
| Industry | Focus Area |
|---|---|
| Medical Devices | Navigation of MDR/IVDR and ISO 10993 compliance. |
| Pharmaceuticals | Impurity profiling and PDE/OEL/OEB derivations. |
| Chemicals & Cosmetics | REACH compliance and safety evaluations. |
| Food Industry | Risk assessment of migration and additives in contact materials. |
A Client-First Approach to Compliance
While our processes are rigorous, they are never bureaucratic. We leverage client feedback to refine our services, ensuring our delivery meets your specific commercial goals without sacrificing scientific or regulatory rigor.
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Global Expertise
Dr. Carsten B. Senholt
Chief Technical Officer & Partner
As the Head of the Danish Delegation to ISO/TC 194 for over 14 years, Dr. Senholt is a key figure in drafting the ISO 10993 series. His leadership ensures that SAXOCON’s technical quality is anchored in the same scientific rigor used to define international standards.