Quality Assurance/Control

• Internal and third party compliance initiatives, auditing and pre-inspections
• Instrument, equipment and process qualifications from assessment through protocol preparation, execution and reporting
• Analytical Studies/Testing
• Drug (API and excepient) Characterization
• Manufacturing batch records review
• QA/QC data and methods review, updating and reporting
• SOP’s, test methods (to multiple applicable standards) development and training