Technical Project Oversight & Analysis

• End-to-end project management for regulatory and analytical milestones across development stages.

• Oversight of method development, validation, and transfer with accredited laboratories.

• Coordination of ICH stability studies, impurity profiling, and degradation pathway analysis.

• Analytical data review for dossier inclusion and readiness for regulatory inspections.

• Risk mitigation strategies and technical troubleshooting for product development delays.