Method Feasibility, Qualification and Validation
Eurofins BioPharma Product Testing Netherlands support customers at various stages of the development / validation process. With our proven track record of success on full development and validation studies, optimization of existing research methods and transfer of previously validated methods, we offer the best expertise in our field to support your needs.
When methods are submitted for qualification or validation, we recommend performing feasibility prior to proceeding. Feasibility allows us to gain familiarity with the method and evaluate the method for attributes such as precision, linearity, accuracy and specificity, avoiding protocol acceptance criteria failures.
Performed on methods supporting early phase products. With a Method qualification, we ensure that the method is appropriate for its intended use.
Performed on methods supporting later phase products. Methods are validated consistent with the USP general chapter and the ICH guidelines. Validation is performed under the direction of a protocol.
Protocol Writing for
- Method Validation/Qualification/Verification
- Method Transfer
- Stability Studies
Why choose Eurofins BioPharma Product Testing Netherlands?
- Single-point-of-contact. Eurofins BioPharma Product Testing Netherlands has all expertises within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins BioPharma Product Testing Netherlands has several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Quick turnaround time on feasibility assessment of the methods, execution of the protocol and generation of the final report.
- A flexible process that allows out-of-the-box thinking and solution driven.