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Integrated Product Development Plan. Formal PMO facilitating Project Schedule, Risk Log, Key Decision Tracker, Change of Scope Log, Action Item tracker, KPI’s, Communication Plan, Meeting Summary Template. Project Schedule Assessment, 4-Panel Summaries
Phase Appropriate Drug Development. Pre-clinical through commercial tailorable list of CMC deliverables to progress from Pre-Clinical ->Clinical QbD process and Analytical Development -> PPQ -> Commercial. This will be rolling wave planning and link to proposal process.
4. Customer/Patient Engagement
Notable Outcomes:
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Best in class Client Experience:
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QbD process and analytical development based approach that aligns with Client CMC and regulatory strategy
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Minimize disconnects between Client + CRDMO from pre-clinical through commercialization
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Industry leading development lead times
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Integrated rolling wave project plan
Internal Customer Service Summary review across (cost, schedule, quality, technical, collaboration), included in monthly BU reviews
Joint Progress Reviews Assessment of key areas independently by Customer and Company prior to FtF review. Focus is to facilitate discussion around what is working well along with any opportunities and associated actions
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