Analytical method development and validation
Ensuring accuracy and reliability of your analytical method
Why method development & validation?
Proper development and validation of analytical methods under GMP are essential for regulatory compliance, quality control, and the overall success of drug development and manufacturing.
By ensuring the accuracy and reliability of analytical methods, pharmaceutical companies can achieve consistent product quality and safety, ultimately leading to better patient outcomes.
Comprehensive method development and validation services
At Particle Analytical we cover the entire analytical method lifecycle using a Quality by Design (QbD) approach. This approach ensures that methods are developed with a systematic understanding of the process and product requirements.
We follow the ICH Q2 and Q14 guidelines to ensure compliance with international standards.
Particle Analytical Method Services
Method Development
Creating reliable and robust methods tailored to your specific requirements.Method Optimization
Enhancing existing methods for greater efficiency, accuracy, and robustness.Method Validation
Ensuring methods meet all regulatory standards for accuracy, precision, specificity, linearity, range, and robustness.Method Transfer
Guaranteeing consistency and accuracy when methods are transferred between laboratories.Method Verification
Confirming established methods perform as expected in new laboratory conditions.We can assist if you face these challenges
Inaccurate Results
Poorly developed methods can produce unreliable data, leading to incorrect conclusions about product quality and safety.Regulatory Non-Compliance
Inadequate validation can result in methods that do not meet regulatory standards, leading to delays in product approval and potential legal issues.Quality Control Failures
Unreliable methods can result in inconsistent product quality, increasing the risk of batch rejections and recalls.Increased Costs
Inefficient methods can lead to increased testing times and higher costs, impacting overall project budgets.Product Safety Concerns
Inaccurate analytical methods can fail to detect impurities or deviations, compromising patient safety.
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How we can help
Learn more about How we can help you addressing problems in your development or manufacturing process, by applying our strong technical and analytical skills.
Knowledge Hub
Explore our Knowledge Hub for regulatory guidelines, publications, events and FAQ, that bring you insights into particle analysis
Why choose us
By choosing Particle Analytical, you get a strong and specialized partner, with a wide range of analysis, scalable and flexible services, and strong accreditations.