Method Development and Validation: Ensuring Precision and Reliability in Product Testing
In the complex world of product testing and quality assurance, standard methods do not always suffice. Our expert team specializes in developing and validating custom analytical methods tailored to your specific products and materials.
Customized Method Development
We go beyond off-the-shelf solutions to create testing protocols that precisely match your needs:
- Standard Adaptation: We refine ASTM, ISO, and USP standards to address your product’s unique characteristics.
- Novel Method Creation: When existing standards fall short, we design entirely new testing approaches.
- Protocol Optimization: Our scientists fine-tune every aspect of the method to maximize accuracy and efficiency.
Comprehensive Validation Studies
Our rigorous validation process ensures your methods are reliable and defensible:
- Accuracy Assessment: We demonstrate that the method consistently produces true results.
- Repeatability/Precision Testing: Through multiple analyses, we confirm the method’s consistency.
- Range Determination: We establish the scope of concentrations or conditions where the method remains effective.
- Linearity Evaluation: We verify the method’s ability to provide results proportional to the quantity being measured.
- Specificity: We verify that the technique will be able to measure the appropriate parameter without being influenced by matrix effects.
Seamless Integration and Transfer
We do not just develop methods; we ensure they work for you:
- Proof-of-Concept Testing: We demonstrate the method’s effectiveness using your actual materials or products.
- Documentation: Detailed protocols are created for easy implementation in your quality control processes.
- Knowledge Transfer: We can train your team to execute the methods in your own facilities.
Supporting Your Regulatory Journey
Our method development and validation services are designed to strengthen your regulatory submissions:
- Design History File Integration: Validation studies can be incorporated into your product development documentation.
- Regulatory Compliance: Our methods are developed with relevant FDA, EMA, and other regulatory guidelines in mind.
Why Choose Our Method Development Services?
- Expertise: Our team has experience across diverse industries and product types.
- Flexibility: We adapt our approach to meet your specific project needs and timelines.
- Advanced Technology: We utilize state-of-the-art analytical instruments to deliver high-quality results.
- End-to-End Support: From initial concept to full implementation, we are with you every step of the way.
Take control of your product quality with custom-tailored testing methods. Contact us today to discuss how our method development and validation services can elevate your quality assurance processes and support your regulatory success.