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CMC&QS
provides support for Chemistry, Manufacturing & Controls
(CMC) activities including project strategy, planning, and
implementation.
Fields of expertise are:
Pharmaceutical Drug Development
- Chemical and Formulation Process Development
- Analytical Method Development and Optimization
- Scale-up
Technology Transfer
- Analytical Methods
- API and FP processes
Validation
- Site Master Plan and Validation Master Plan
- Analytical Method
- API and FP process validation
CMC
Documentation W
- Creation and review of technical source documents
- Creation and review of CMC regulatory submission documents
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