Ensure Compatibility and Patient Safety

Medical devices intended for the delivery of medicinal products can significantly impact the quality, safety, and efficacy profile of those products. The EU mandates specific, additional information for devices that are co-packaged or cross-labelled for drug delivery. Any interaction between the device materials and the drug must be rigorously characterized to prevent therapeutic degradation or toxicological risk.

SAXOCON provides the specialized expertise required to test and document compatibility in full compliance with regulatory requirements, including:

• Material Characterization:
  Expert selection, screening, and characterization of construction materials for delivery devices.
• Analytical Oversight:
  Selecting qualified laboratories, reviewing technical protocols, and monitoring Extractables and Leachables (E&L) studies.
• Toxicological Risk Assessment:
  Data-driven evaluation of analytical results to ensure product stability and safety.

Why Choose SAXOCON?

Our services for the development of device-drug combination products provide you with:

• Best-in-Class Experience:
  Extensive history navigating the complex regulatory landscape where international device standards meet pharmaceutical guidelines.
• A Multidisciplinary Team:
  Direct access to expert toxicologists, material scientists, and supply chain professionals who understand the drug-device interface.
• Exclusive Data Insights:
  Safety evaluations bolstered by non-disclosed information obtained from our global network of material suppliers.
• Strategic Efficiency:
  Smart, cost-effective test strategies that minimize delays and accelerate your time-to-market.

Delivery

SAXOCON compiles all additional documentation necessary for developing a new Drug Application file in accordance with EMA and FDA requirements. Our deliverables ensure that the biological and chemical safety sections of your technical file are robust, compliant, and audit-ready.