The Foundation of Reliable Science
Method validation is not just a regulatory requirement—it's the cornerstone of credible research and development. Without properly validated methods, even the most promising compounds can fail to reach market, and critical data integrity can be compromised. Smithers eliminates this risk by providing scientifically rigorous validation services that give you complete confidence in your analytical results.
Comprehensive Method Validation Solutions
Analytical Performance Testing
We conduct thorough evaluations of your method's fundamental performance characteristics. Our testing protocols assess accuracy, sensitivity, specificity, and precision using scientifically validated techniques and state-of-the-art equipment. Every parameter is rigorously examined to ensure your methods deliver consistent, reliable results that meet the most stringent scientific standards.
Regulatory Compliance Assurance
Navigate complex global regulatory landscapes with confidence. Our team maintains deep expertise in FDA, EMA, ICH, and other international guidelines, ensuring your validated methods satisfy all relevant regulatory requirements. We stay current with evolving standards so your methods remain compliant throughout their lifecycle.
Cross-Platform Validation
When your methods must perform consistently across multiple platforms or instruments, we provide comprehensive cross-validation services. Our systematic approach ensures reliable, reproducible results regardless of the analytical platform, eliminating variability that could compromise your data integrity.
Drug Specific Assays
• ISR, Parallelism
• Bridging PK method from multiple platforms
• Cross-validation between laboratories
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How can we help?
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- Method Development
- Method Validation
- Pharmacokinetics and Toxicokinetics Testing
- Immunogenicity Testing
- Biomarker Services
- Molecular Biology Services