I + D + Quality control
The development and improvement of a product requires the use of contemporary analytical techniques, such as GCMS, LCMS or microscopy (SEM, TEM and/or AFM), which help to understand the steps of development and modification.
Moreover, for quality control, there are a lot of types of cases of non-conforming products: presence of impurity in the finished product, which can be detected by the quality control process of the manufacturer, or the operator during manufacturing, or in the worst cases, by the end customer.
CSI Analytica has extensive experience in the identification of different kinds of impurities, which are identified by several analytical techniques (IR, GC and LC - MS, SEM, TEM, AFM, etc), making high-quality, clear and complete Analytical Reports so our customers can make important decisions. Also, we have knowledge of GMP and GLP regulations, and we can work under these rules.
The registration of a generic drug requires pharmacokinetic studies comparing the absorption of the registered drug with the generic (without brand) which one wants to register. For this purpose, analytical techniques, such as GCMS or LCMS with triple quadrupole analyzer, and skilled technicians are required. This analysis should be performed under GLP regulation following the European guidelines for bioanalytical methods.
CSI Analitica staff participates in pharmacokinetic studies of products for humans or animals by LCMS, under the same European guidelines.