Are you looking for advice or support on GMP stability studies for your product?
QbD is happy to be at your service. In our GMP laboratory at Quercus (Ghent) we have mapped all ICH requirements and can monitor them on-site for you.
Our team consists of experienced stability staff who can advise you on best practices when conducting your stability studies.
Don’t hesitate to contact us for more information about our stability study services.
What is a Stability Study?
A stability study is a regulatory and GMP requirement to support the shelf life of your medicinal product throughout its life cycle.
We have in-house ICH stability cabinets to store your stability samples in a GMP compliant manner.
In addition, we have all the necessary QC analytical capabilities and an in-house microbiology laboratory to support our customers with the analysis of stability samples.
The final report for submission to the authorities can also be written by our experts.
Why QbD Group ?
Stability data of pharmaceutical products is essential to understand the behavior of your products during the shelf life or during patient use.
A knowledgeable partner like QbD can ensure that you generate accurate and relevant stability data for your products.
Quercus holds a GMP license, an ISO 17025 certificate, and is audited by the Belgian FAGG. We have sufficient capabilities to meet your QC needs.
This will allow you to allocate your internal resources to your core activities such as R&D or production.
Outsource your stability study
You can outsource your full stability study to Quercus, including storage, analysis, and reporting.
Once we receive a request for analysis, you will receive a detailed quote and a lead time for reporting the analysis results.
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.