Services for method establishment
Prior to starting any project, we will discuss the project requirements with the client to ensure an appropriate scope is defined. We utilize our knowledge of method development on hundreds of products to assist with the development process. We evaluate attributes such as precision, linearity, accuracy and specificity during development to ensure the method is suitable for validation.
Methods may be optimized for a variety of reasons, including improving separation of a critical peak pair, or supporting a formulation change. In addition, methods not validated to current industry standards may require optimization to allow for successful validation.
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 with the hopes of avoiding protocol acceptance criteria failures.
Why choose Eurofins BioPharma Product Testing Netherlands?
- Experienced project leaders collaborate closely with our customers to set up a strategis method development plan.
- Quick turnaround time on feasibility assessment of the methods.
- A flexible process thet allows out-of-the-box thinking and solution driven.