SmithBio offers total cGMP compliant design, engineering, procurement, validation and project management support that meets your highest expectations, for pilot-scale facilities and cGMP production facilities.
We work closely together with you throughout the whole project and our project managers can support every step of the project to make sure all requirements and specifications are met within the set timelines.
Our team is available to provide turnkey support for pilot-scale and production up-scaling facilities, including
- translate cURS to production process parameters
- support facility concept and basic design engineering
- optimize production process, quality, efficiency and productivity increase
- support scaling-up production.
Our team is available to provide turnkey support for full production facilities, including
- support facility concept and basic design engineering
- team formation
- project management support (including for preparation of bidding documents, supplier selection and contract signing)
- final SAT and validation support, including for PQ
- regulatory compliance support, including for product certification/registration.
Our experienced team of engineers and project managers have an in-depth understanding of industrial processing and have successfully completed many turnkey projects.