Regulatory Support

Corporate Quality Oversight
- QA functions at every site with corporate with oversight
- System oversight: training, change control, calibration, vendor qualification
- Audit internal systems & contract service providers
- Maintain follow-up system for audits, corrective actions and trend analyses
Focus on quality detail
- Review, approval and control of all quality-related documentation
- Release and rejection of all raw materials, intermediates, and final products
- Investigation of deviations, OOS results and quality-related complaints
Drug development strtegy and technology transfer risk management analyses
CMC Strategy, Planning & Development
Regulatory Strategy Development
Drug Substance Dossier Preparation