Release analytics
Quality assurance for your products
We check the quality of your products and medicines.
Independent, accredited and certified release analysis by experienced chemists and laboratory technicians.
Laboratory controls and release analyses are essential for GMP products. When releasing medicinal products, for example, identity, purity and content tests are carried out in accordance with current regulations.
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Outsourcing order analyses
As an established provider of drug analysis in Switzerland, we specialize in release testing and have the necessary accreditations and certifications according to ISO/IEC 17025 and GMP. We see ourselves as an integral part of your quality system and carry out chemical release tests to ensure the quality of your products.
Our comprehensive range of services is based on holistic analytical solutions aimed at relieving or supplementing your in-house laboratories through outsourcing. In our state-of-the-art laboratory, we can perform a variety of analytical methods (a overview of all methods) in-house and thus offer you approval tests from a single source. Our analysis portfolio includes chemical, spectroscopic, chromatographic tests as well as titrations.
Validation of release methods: safe and reliable analysis procedures
GMP release testing requires the use of validated methods. For new products, suitable analytical methods must be developed for release or stability studies. This requires extensive chemical and analytical expertise to develop the appropriate procedure. Read more about our method development, validation and transfer.
The analytical methods of a product must be validated at the latest before the start of clinical studies, i.e. before use in humans. The validation of an analytical method ensures that the selected procedure is suitable and applicable for the intended purpose of the analysis. The determination of the required method parameters depends on the type of analysis and is described in the ICH guideline Q2(R2) and the FDA guidelines.
Product releases
Carrying out quality controls for product release: according to your specifications and process instructions.
We analyze your samples when performing the release tests in accordance with your specifications, the transferred analytical procedure instructions or our own validated analytical methods. As soon as we have received the order, we carry out the tests quickly in accordance with the agreed specifications.
Infrastructure
Wir verfügen über eine breite Palette von analytischen Methoden und Instrumenten zur qualitativen und quantitativen Charakterisierung von Proben.
Neben Geräten und Methoden für die spektroskopische und chromatographische Analytik gehören auch weitere Methoden wie REM/EDX, TGA, TMA, DMA, DSC, … zu unseren Analysemöglichkeiten.We have a wide range of analytical methods and instruments for the qualitative and quantitative characterization of samples.
In addition to devices and methods for spectroscopic and chromatographic analysis, other methods such as REM/EDX, TGA, TMA, DMA, DSC, … to our analysis options.
