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