Method Development, Validation and Transfer

At Eurofins BioPharma Product Testing, we offer a comprehensive suite of services in analytical method development, validation, transfer, and life cycle management for your Biopharmaceutical product. Our goal is to provide you with robust, reproducible, and compliant methods that support your product from development through to commercialization.

Our highly skilled method development scientists have gained many years of experience and are familiar with different types of products, methods, and technologies. Your method is designed to create precise and reliable analytical procedures tailored to the specific needs of your biopharmaceutical product. Leveraging state-of-the-art technologies and our deep scientific knowledge, we develop methods that are

Validation is a critical step to confirm that your methods consistently produce reliable results. Phase-appropriate validations are conducted in accordance with ICH guidelines such as ICH Q2(R2) and other relevant regulatory standards (like EMA or US FDA), ensuring your methods meet the highest industry benchmarks. We thoroughly assess parameters such as accuracy, precision, specificity, and range, providing you with detailed client-specific validation reports that support your regulatory submissions.

Transferring analytical methods from one laboratory to another requires careful planning and execution to maintain method integrity and compliance. To ensure a seamless transfer of methods across sites or to external partners we work closely with you to manage all aspects of the transfer process, from documentation and analyst training to troubleshooting and experimental work.

Analytical methods evolve throughout the product life cycle to address changing needs, regulatory expectations, and technological advancements. We ensure your methods remain effective and compliant early-stage development through to commercial use. We offer continuous monitoring, periodic reviews, and updates to your methods, helping you navigate post-approval changes, and global regulatory demands.

Contact our team to discuss your specific needs or explore our website for more details on our comprehensive biopharmaceutical testing services.

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