Our Services – Pharmaceuticals & Veterinary Medicine
Method development and validation
Method Development and Validation for the Pharmaceutical and Veterinary Medicine Industries
Developing and validating analytical methods is often complex and labour-intensive, requiring a good understanding of current regulations, relevant chemistries, and the use of appropriate instrumentation. CEMAS has experienced scientists who ensure the bespoke method development and validation solutions offered are designed to meet your specific requirements, and those of the healthcare and veterinary medicine industries. Our teams and custom-built laboratories, ensure the efficient creation of robust, reliable, and regulatory-compliant analytical methods and data, essential for drug development and approval.
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| Phase | Pharmaceutical/Veterinary Medicine Industry |
|---|---|
| Method Development | Analytical Method Development Bioanalytical Method Development Stability-Indicating Method Development |
| Method Validation | Method Validation (ICH/VICH Guidelines) Bioanalytical Method Validation Stability Method Validation |
| Ongoing Support | Method Transfer and Optimisation Cross-Validation Support Cross-Validation Support |
Our Method Development Services typically involve a 6-step approach:
- Initial discussion: Understanding your requirements and objectives.
- Review and feasibility: Researching existing methods, consulting with our multi-disciplinary
development team and identifying potential techniques. - Experimental Design: Creating a robust plan for method development.
- Method optimisation: Fine-tuning parameters to enhance sensitivity, specificity, and robustness.
- Testing: Running preliminary experiments to validate the method’s performance.
- Continued communication: our customer-centric ethos; ensuring you are kept updated, every step of the way.
Method Validation overview:
- Accuracy: Assessing how close the results are to the true value.
- Precision: Evaluating the reproducibility of the method under the same conditions over time.
- Specificity: Ensuring the method can accurately measure the target analyte without interference.
- Linearity: Demonstrating the method’s ability to obtain test results that are directly proportional to the concentration of analyte in the sample.
- Range: Determining the upper and lower limits of the method.
- Sensitivity: Determining the method’s limit of detection (LOD) and limit of quantification (LOQ).
- Robustness: Testing the method’s reliability under varied conditions.
- System suitability confirmation: Verifying that the analytical system is performing correctly.
Below are our suggested validation requirements at different phases of clinical trials
(Early Phase: Phases 1-2, Late Phase: Phases 3+)
| Assay | Impurities | |||
|---|---|---|---|---|
| Validation Partner | Early | Late | Early | Late |
| Specificity | X | X | X | X |
| Force degradation | X | X | ||
| API | X | X | X | X |
| Known impurities/excipients | X | X | X | X |
| Accuracy | X | X | X | X |
| Precision | X | X | X | X |
| System repeatability | X | X | X | X |
| Method repeatability | X | X | X | X |
| Intermediate precision | X | X | ||
| LOD | X | X | ||
| LOQ | X | X | ||
| Linearity | X | X | X | X |
| Range | X | X | X | X |
| Robustness | X | X | ||
| Solution stability | X | X | X | X |
Our method validation service ensures that our developed method is suitable for its intended purpose, and that the method produces reliable results within specified limits that can be consistently reproduced.
Method Transfer and Optimisation Services help in integrating new methods into your existing workflows, or enhancing current methods for better performance.
Regulatory Compliance
We provide thorough support to ensure your methods and documentation meet all relevant regulatory standards, and can provide testing adhering to the latest GLP, GCP and/or GMP guidelines, as required for pre-clinical, clinical and manufactured product studies.
Why choose CEMAS?
Science
Our scientists and study directors bring decades of experience and expertise
Compliance
GLP, GCP and GMP compliance to ensure that your regulatory needs are met
Delivery
Flexibility and responsiveness to your requirements, to provide quality data on time
Reliability
Quality and delivery are at the heart of all we do
