Analytical methods should be evaluated and applied correctly to guarantee the quality of pharmaceutical products. The development and validation of analytical methods are critical ongoing efforts throughout the drug development process
During the method development phase, optimization of laboratory facilities is at the forefront. At this stage, accurately determining the detection and quantity of the substance to be tested for routine sample analysis is a critical step
At the method validation stage, it is aimed that the method accurately measures the parameters to be tested as intended. Here, the efficient transfer of the method on a global scale is guaranteed. Method development and validation studies are important to demonstrate that the data obtained are reliable, precise and accurate.
Our team has deep knowledge and many years of experience in developing methods for hundreds of different dosage-form products and raw materials through scientific literature and various publications at international conferences. Method validation studies are conducted in accordance with FDA, USP, EP, BP, and ICH guidelines to confirm the suitability of the developed method for its intended use.
All necessary documents are prepared in line with quality requirements for studies such as method validation, partial method validation, re-validation and method transfer.
