Harmonize Global Compliance and Strategic Development

For pharmaceutical manufacturers, a delivery device is more than a container, it is a critical component of the drug product’s safety and efficacy profile. Navigating the overlapping regulations for combination products is complex, as requirements are rarely harmonized across global markets. SAXOCON provides a unified strategy to align device characterization with your drug development milestones, preventing redundant testing and ensuring a smooth path to approval.

SAXOCON provides a cost-effective roadmap to bridge the gap between drug and device development, including:

• Integrated Development Planning:
  Synchronizing device test strategies with drug product stability and clinical activities to justify the overall safety case.
• Material and Interface Characterization:
  Expert screening of delivery components to ensure chemical and biological compatibility with the drug substance.
• Regulatory Advocacy: Strategic assistance during scientific advisory meetings to address combination product requirements with the FDA (CDER/CBER) and EMA.
• Analytical Oversight:
  Selecting qualified laboratories and monitoring Extractables and Leachables (E&L) studies specifically for the drug-device interface.
• Toxicological Risk Assessment:
  Final data analysis to confirm that the combination product meets all safety requirements for human use.

Why choose SAXOCON?

Our approach allows pharmaceutical teams to manage multi-layered regulatory risks with confidence:

• Pharmaceutical-First Perspective:
  High-level experience in state-of-the-art safety assessments designed to support pharmaceutical quality requirements.
• Unmatched Cross-Sector Experience:
  Deep expertise in the international standards (ISO and USP) that govern the hardware of drug delivery.
• Multidisciplinary Precision:
  A team of toxicologists and material scientists who understand the molecular interactions between drugs and delivery systems.
• Supplier-Level Data:
  Access to non-disclosed material information from our global network to support your risk assessments and regulatory filings.

Delivery

SAXOCON compiles the comprehensive documentation required for your New Drug Application or Marketing Authorisation Application. Our deliverables ensure that the combination product sections of your dossier are robust, compliant, and ready for global regulatory scrutiny.