SYSTEMS EVALUATION
- Implementing quality by design for successful commercialization
- Analyzing and managing risk in the R&D and manufacturing environments
- Developing requirements and performing audits for clinical material GMP (Phases I, II, and III)
- Assessing and streamlining development practices
In the realm of quality control and quality assurance systems, which include:
- Assessing and managing risk vis-à-vis quality systems
- Evaluating and enhancing quality unit roles and responsibilities
- Assessing and improving facilities and equipment systems, materials systems, production systems, and laboratory controls systems