End-to-end method expertise
Whether you're developing a method from scratch, transferring an existing one, or remediating deficiencies in validation, you need results you can trust—fast. Add evolving standards, formulation changes, and the demand for shorter run times, and the challenge only intensifies. The Eurofins BioPharma Product Testing (BPT) network of laboratories provides end-to-end support to help you meet these challenges with confidence. Our approach is structured, science-driven, and built to minimise variability at every stage of method development. We align our expertise to your needs, offering scalable support for a wide range of analytical method establishment services.
At Eurofins BPT our teams deliver unmatched expertise, completing hundreds of validations, qualifications, verifications, and method transfers each year. This depth of experience enables us to develop innovative, robust, and effective analytical methods tailored to your needs. Whether you require a method for stability studies, need to optimise an existing method, support a formulation change, align with current regulatory expectations, or reduce run times, we can help.
We also support the development and validation of robust methods using the Analytical Quality by Design (AQbD) framework, guiding you through each stage—from Analytical Target Profile (ATP)—to Establishment of a control strategy.
Before initiating any project, we consult with clients to define a clear, appropriate scope. Drawing on extensive experience across hundreds of products, we apply best practices in method development and integrate principles of Analytical Quality by Design (AQbD). Key performance attributes—such as precision, linearity, accuracy, and specificity—are assessed during development to ensure the method is robust and ready for validation.
Methods may require optimisation to improve peak resolution, accommodate formulation changes, or meet evolving regulatory expectations. Older or underperforming methods can be refined to ensure they are suitable for successful validation under current industry standards.
We recommend conducting feasibility studies before progressing to method validation. This step allows our scientists to familiarise themselves with the method and assess key attributes—including precision, linearity, accuracy, and specificity—helping reduce the risk of failing protocol-defined acceptance criteria.
Early phase validation ensures the method is fit for its intended purpose during clinical development. This phase-appropriate validation may be conducted with or without a formal protocol, depending on the project’s requirements.
Designed for methods supporting later-stage development, this validation follows Ph. Eur., USP, and ICH guidelines. All validations are executed under the direction of a defined protocol to ensure regulatory compliance and data integrity.
Verification is carried out on compendial methods to confirm acceptable performance with your specific API or product matrix. This process, guided by protocol, ensures suitability and consistency in real-world application.
Method Validation/Verification, Method Transfer