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Analytical Method Development and Validation
Fit-for-purpose methods for new APIs, drug products and excipients.
Development of analytical methods for new active pharmaceutical ingredients, drug products and excipients is an ongoing requirement across the pharmaceutical industry. Method development, validation and transfer are the first step in establishing product quality and enabling routine sample analysis.
Our team includes lead scientists with over 20 years’ experience in method development and validation. Drawing on that experience, we guide you to the most suitable method for your product, in line with regulatory expectations.
We specialise in methods for
- Stability-indicating assay methods
- Assay of single drugs and multi-drug combinations
- Impurity profiling methods
- Residue or cleaning methods for single and multiple drugs
- Dissolution methods with shorter run time
- Organic volatile impurities and residual solvents
- Critical excipients such as preservatives and stabilisers
- Multivitamin formulations
All methods developed by our connected laboratory are validated as per current ICH Q2 guidelines.