Mitigate Migration Risks and Ensure Product Integrity

Primary packaging systems, including containers, closures, and delivery components, must be meticulously characterized to ensure they do not alter the safety or efficacy of the drug product. SAXOCON provides the rigorous testing and documentation necessary to prove that your packaging remains inert and compliant throughout the product’s shelf life.

SAXOCON provides the technical oversight required to document compliance with global packaging standards, including:

• Material Selection:
  Expert screening and characterization of construction materials to minimize interaction with the drug substance.
• Regulatory Risk Analysis:
  Comprehensive assessments conducted in accordance with ICH, EMA, and FDA guidelines.
• E&L Strategy:
  Designing Extractables and Leachables test strategies that meet European and US Pharmacopoeia requirements.
• Study Monitoring:
  Reviewing technical protocols and providing active monitoring of E&L studies to ensure data quality.
• Toxicological Risk Assessment:
• Expert evaluation of analytical results to confirm the safety of the packaging-drug interface.

Why Choose SAXOCON?

Our pharmaceutical packaging services provide the technical assurance needed for global submissions:

• Multidisciplinary Expertise:
  A specialized team of toxicologists and material scientists who understand the chemical complexities of packaging migration.
• Exclusive Data Insights:
  Safety evaluations informed by non-disclosed information obtained from our worldwide network of material suppliers.
• State-of-the-Art Assessments:
  Proven experience in safety evaluations that align with the latest international standards and regional regulatory guidelines.
• Commercial Efficiency:
  Smart, cost-effective test strategies designed to eliminate regulatory roadblocks and accelerate your time-to-market.

Delivery

SAXOCON compiles all necessary evidence into an audit-ready expert report for your New Drug Application or Marketing Authorisation Application. Our deliverables are specifically tailored to fulfil ICH Q8, FDA, and EMA requirements, ensuring your packaging files are robust and defensible.