Biodextris services

Biodextris supports you in the design of a suite of analytical assays that assess the important and critical quality attributes for your unique product. Our team of talented scientists follow a systematic structured methodology to develop each assay optimized for your product.

Validation of a method is a critical step of development work. We, at Biodextris, validate your assays to demonstrate that the appropriate performance criteria are met, and the analytical target profile is achieved. Our quality management system ensures validation policies are aligned with the ICH method validation guidelines ICH Q2(R1).

Our clients and their situations are all different and as such Biodextris can offer up a wide array of options when it comes to method transfer. On inward bound method transfers we can take in a method and simply transfer and execute, or if requested, we can offer our expertise to further optimize it. With outward bound transfers we offer full support to help our clients (and their partners) get our new methods up and running with comprehensive documentation and access to our team’s expertise. Quality is our guarantee!

Clinical Drug Substance/Product Analysis: We support you to confidently release your clinical product by executing validated assays which form the backbone of your product monograph or IND CMC section, and establish the quality, efficacy and safety of your product. Our technologies allow complete analysis of bulk drug substance and liquid or lyophilized drug product, and the validated analytical methods are performed under rigorous quality oversight, following defined standard operating procedures. Your data integrity is assured and your results are handled securely.