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.
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.
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.
Protocol Writing for
- Method Validation/Qualification/Verification
- Method Transfer
- Stability Studies
- 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 services. Whenever necessary, additional services like pure culturing and/or testing of more, other genes can be provided. Please contact us if you want to discuss your needs.