Goals of our Technology Transfer Department
Review of all registered product documentation and perform of Gap analysis.
Take all the gathered knowledge and use it as the basis for the manufacturing control strategy.
Ensure variability of process and parameters are controlled and sufficient in the face of the rigors of a commercial production environment.
Transition of the product/process/analytical method knowledge between development and manufacturing sites.
Production of scale up batches.
Verification of the parameters established during development are still within the determined design space and/or adjusted at scale-up
Stability testing of scale up and validation/registration batches.
Goals of our Technology Transfer Department
Review of all registered product documentation and perform of Gap analysis.
Take all the gathered knowledge and use it as the basis for the manufacturing control strategy.
Ensure variability of process and parameters are controlled and sufficient in the face of the rigors of a commercial production environment.
Transition of the product/process/analytical method knowledge between development and manufacturing sites.
Production of scale up batches.
Verification of the parameters established during development are still within the determined design space and/or adjusted at scale-up.
Stability testing of scale up and validation/registration batches.
With more than
years of
experience
active ingredients manufactured in our site
MAs granted
globally
formulations under development