Method Development / Validation
Nelson Labs Europe has extensive experience in the development of analytical, bioanalytical, and microbiological methods.
We have experience in developing analytical methods for the complete range of our analytical portfolio, and for the entire lifecycle of a drug. Typical applications are:
- Quality control of APIs, starting material, intermediates, finished products, impurities, and degradation products
- Stability testing
- Characterization of substances, identification of impurities and degradation products
- Forced degradation studies
- Container-closure testing, extractables and leachables
- In support of pre- and clinical sample analysis
At the method development stage, initial validation tests are performed to ensure that the method is reproducible and suitable for its intended use. When used in a GMP or GLP environment, methods are formally validated following the ICH Q2R1 guidelines, including preparation of validation protocols and reports. To provide cost-effective solutions, Nelson Labs Europe offers validation programs adapted to the development stage of the drug, and in line with the customer’s internal quality requirements.