Design practical CMC strategies

• Develop phase-appropriate CMC milestone planning and risk assessments. 

• Execut QbD activities, from TPP/QTPP through CQA, CPP and CMA assessments to draft Control Strategy.  

• Design clinical-to-commercial process development roadmaps and product supply strategy

• Generate CMC source document: quality risk assessments, protocols, reports. 

• Author briefing booklets, eCTD Module 3 for IND/IMPD/BLA/MAA and perform layered review. 

• Support FDA and EMA interactions 

Outcome: A clear, integrated CMC roadmap that supports development milestones, regulatory submissions, manufacturing execution, and product supply