Methods
Die Tentamus Pharma & Med-Labore entwickeln und validieren effiziente und robuste Methoden und Prüfroutinen und unterstützen bei Methodentransfers.
As a pharmaceutical contract laboratory, our work is usually governed by the standardised regulations of national and international pharmacopoeias. However, special sample specifications or the lack of a standardised testing procedure often require the development of specific testing methods. Equally, changes in pharmaceutical formulations or regulatory provisions could mean that the testing methods for a product need to be adapted.
The demanding task of developing a scientifically reliable and economically viable testing method is in safe hands with the experienced analysts at Tentamus Pharma & Med Deutschland.
Method development and validation
for pharmaceutical analytics
Method development and validation
We consult closely with our clients to develop and validate efficient and robust analytical methods that ensure reliable testing routines. We maintain this transparent approach when preparing validation plans and reports that enable methods to be validated in accordance with the ICH Q2 (R1) guideline.
Method transfer
We are happy to cooperate with other analytics providers if established methods need to be exchanged between two laboratories. We help plan and coordinate the transfer of specific methods – either to or from us – and are happy to take over project management and transfer documentation duties.
Method verification
We check whether each of our analytical methods is suitable in practice and verify the results in accordance with pharmacopoeial regulations.