Whether you need expert testing consultation, method development or validation protocol design, Eurofins Sinensis offers you the widest range of laboratory techniques in the industry. We support customers at various stages of the development / validation process and have a proven track record of success on full development and validation studies, optimization of existing research methods and transfer of previously validated methods.
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.
- Method Optimization
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.
- Method Feasibility
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.
- Method Qualification
Performed on methods supporting early phase product. Performed to ensure method is appropriate for its intended use. Qualification may or may not be performed under the direction of the protocol.
- Method Validation
Performed on methods supporting later phase product. Methods are validated consistent with the USP general chapter and the ICH guidelines. Validation is performed under the direction of a protocol.
- Method Verification
Performed on compendial methods to ensure that the methods perform acceptably on your API or product matrix. Verification is performed under the direction of a protocol.
Method Development and Validation Services For:
- Assay/Potency, Purity/Impurity, Dissolution
- Cleaning Validation Analysis (Specific and Nonspecific analyses)
- Assay, Impurity and Dissolution methods for Comparator products
- Residual/Impurities Testing
- Bacteriostatis/Fungistatis for Sterility
- Inhibition/Enhancement Screening for Endotoxin
- AET and Microbial Limit
Molecular and Cell Biology
- Cell-based Assays • ELISA
Protocol Writing for
- Method Validation/Qualification/Verification
- Method Transfer
- Stability Studies
If you have any questions regarding our services, please do not hestitate to contact us to find out whether we can help.
- Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Standard and custom solutions. If our standard solutions do not fullfil your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.