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Quality CMC Consulting
Raleigh-Durham area, North Carolina, United Statesqualitycmcconsulting.com ↗
- Ownership
- Private
- Development stage
- Other
01
Overview
Quality CMC Consulting is an award-winning pharmaceutical development consulting firm specializing in Chemistry, Manufacturing & Controls (CMC), regulatory strategy, technical operations, and quality systems. It helps biopharma companies navigate drug development from early-stage to commercialization by providing strategic guidance on regulatory submissions (pre-INDs/INDs/CTAs/NDA), outsourcing/CDMO selection, risk mitigation strategies for novel therapies/platforms—including biologics and cell/gene therapies—and lifecycle management. The firm has played key roles in advancing first-in-class programs spun out of leading academic institutions.
- Modalities
- Small moleculeBiologicCell therapyGene therapy
- Industry
- Consulting
02
Partnerships
The company works with global pharma/biotech/cell & gene therapy firms as clients but no specific major partnerships are listed publicly.
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