Tech Transfer
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
0
active ingredients manufactured in our site
0
MAs granted globally
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formulations under development
0