Formulation Development Services
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Formulation Development Services
To optimize the formulation and scale-up for the cGMP manufacturing of clinical trial materials for Phase I and Phase II trials, Tou Pharma Bio’ formulation development team and manufacturing unit worked together. Tou Pharma Bio cGMP manufacturing team is under the jurisdiction of the Quality Assurance Unit and complies with Tou Pharma Bio’ Standard Operating Procedures and FDA Guidelines.
Tou Pharma Bio provides the following cGMP manufacturing services.
- Clinical trial materials manufacturing for Phase I and Phase II
- Scale up from R&D to cGMP manufacturing
- Drug Development Process
- Formulation optimization for manufacturing of drug product
- Release testing
- Technology transfer
- Certificates of Analysis