For new products, it is essential to develop suitable analysis methods for release or for stability testing. As a GMP-accredited and FDA-approved contract laboratory in Switzerland, we can draw on an enormous wealth of knowledge and can contribute to your achieving the desired result quickly with targeted literature research and feasibility studies.
The validation of analytical methods is demanded in the GMP regulations. The methods of analysis for a product must be validated at the latest before the start of clinical trials. Fully comprehensive validation in accordance with the ICH and FDA guidelines up until approval is absolutely necessary. Validation of an analytical method provides evidence that the selected method is both suitable and applicable for the analysis purposes intended.
The scope of the validation will be determined together with you in a validation protocol. The experimental work will be carried out by qualified and trained personnel and the results will be summarised in a comprehensive validation report.
Do you require support in method development, or would you like to know whether product-specific validation is necessary?