Clinical Drug Substances
We provide chemical synthesis and manufacturing services for our customers under strict US and international cGMP guidelines.
All equipment has been validated to meet international regulatory requirements including :
- Design Qualification (DQ)
- Construction, Installation and Commissioning Qualification (IQ)
- Operation Qualification (OQ)
- Performance and Process Qualification (PQ)
On-going validation maintenance will be documented using the SAP Enterprise Resource Planning (ERP) Information Systems module dedicated to this function.
All facilities and manufacturing techniques used in the manufacture of products for clinical use or for sale in the United States must be operated in conformity with US FDA & international cGMP guidelines.
Our main facility in Taiwan and China have production facilities and quarantine and restricted access storage necessary for conducting cGMP manufacturing in quantities sufficient for conducting Phase I clinical trials (up to approximately 10 kilograms), Phase II and Phase III clinical trials (between 10 and 100 kilograms) as well as commercial product quantities (greater than 100 kilograms to metric tons).