Method Validation as per ICH & USP Guidelines
At Cubic Analytical Solution, we offer comprehensive Method Validation services to ensure that your analytical methods meet the stringent standards set by the International Council for Harmonisation (ICH) and United States Pharmacopeia (USP). Method validation is a crucial step in ensuring the accuracy, reliability, and consistency of analytical techniques used in the pharmaceutical, cosmetic, and food industries.
Guidelines for Method Validation: ICH & USP Compliance
Comprehensive Method Validation
We validate analytical methods following ICH (Q2) and USP guidelines, ensuring methods are robust, reproducible, and compliant with regulatory requirements. Our validation process evaluates key parameters such as accuracy, precision, specificity, linearity, limit of detection (LOD), and quantification.
ICH & USP Compliance
Both ICH and USP guidelines provide a framework for method validation, ensuring that analytical techniques can consistently produce accurate and reliable results. By adhering to these guidelines, we guarantee that your methods will meet regulatory expectations across regions and markets, ensuring your product’s safety and efficacy.
Importance of Method Validation
Validating your analytical methods is critical to maintaining the quality and safety of your products. Whether you are testing active pharmaceutical ingredients (APIs), excipients, impurities, or finished products, proper method validation ensures that your methods consistently provide reliable data.
Tailored Validation Services
We offer flexible validation services tailored to your specific requirements, whether you need to validate newly developed methods or revalidate existing ones. Our experienced team works closely with you to design validation strategies that fit your product specifications, process requirements, and regulatory needs.
Regulatory Compliance Support
We provide comprehensive end-to-end support to ensure your analytical methods consistently meet all regulatory requirements. We assist with preparing detailed validation reports and supporting documentation for regulatory audits, helping you achieve smooth approval for your products.
Expert Consultation and Support
Beyond performing method validation, we offer expert consultation services to help you optimize your methods and ensure they meet regulatory standards. Our team provides guidance on method development, validation protocols, and troubleshooting to ensure that your methods are both efficient and compliant.
Why Choose Us?
Cubicana’s team of experts combines industry experience with the latest technologies to deliver precise and reliable method validation services. Our commitment to quality and regulatory compliance ensures that your analytical methods meet the highest standards, allowing you to confidently move forward in product development and regulatory submissions.