Analytical method validation reports form an integral part of product dossiers for the approval of pharmaceutical products and pharmaceutical substances.
Nowadays all countries require that analytical method validation reports with complete chromatograms and raw data must be submitted along with the dossiers for evaluation and approval of the products.
Method validation is defined as the generation of documented evidence which establishes the suitability of the method for its intended use. As part of the method validation, a number of parameters are required to be established and must meet the global acceptance criteria laid down under the ICH / harmonized guidelines.
We can also help with Nitrosoamine validation (All analytes- NDMA,NDEA,NMPA,NDIPA, NIPEA,NDBA, NMBA)
Feel free to contact us if you have any questions regarding validation studies. Our experts can help to answer your questions about your specific project.