A standard GxP-requirement is qualification and/or validation of critical aspects of particular operations, both initially and after changes to facilities, equipment, processes and materials. Also, scientific developments, changes in regulatory requirements and updating of market authorizations may lead to changes that require revalidation. Eurofins Sinensis is here to help you.
How can we help?
Validation should be the easiest part of the development and qualification process, since it essentially only comprises statistically sound proof that facilities, equipment and processes comply to predetermined specifications. Shortcuts in development, positive expectations and budget restrictions very often lead to failures during validation.
The experienced staff of Sinensis can support you in the design of the development and validation processes, determination appropriate and scientifically sound specifications, performance of pre-validation confirmatory studies and the final validation, resulting in protocols and reports that are acceptable to the regulatory authorities.
Many topics require a different approach to validation.
Please select a specific topic on the left of this page to learn more about our competences and customer-approach. If you want to discuss your project or request a quotation, feel free to contact us.
- 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.