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Initial strategic consulting phase evaluating therapeutic intent, target molecules, excipient compatibility, and regulatory pathway de-risking.
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Active bench compounding and Chemistry, Manufacturing, and Controls (CMC) optimization for scheduled medicines and advanced delivery systems.
Pilot-scale validation, process parameter freeze, CTD Module 2 & 3 drafting, and full technology transfer to commercial contract manufacturer.
Institutional capacity model covering up to 90 hours/month of dedicated scientific research, agile bench sprints, screening assays, and CMO oversight.