- Contract Supplier Management for
- Contract manufacturers of drug substance (API) and drug product (final dosage forms)
- Contract labeling and packaging providers
- Contract laboratories for
- GMP release testing
- GLP preclinical studies
- GCP central laboratory testing
- Bioanalytical testing from GLP or GCP studies
- Facility Construction and Start Up
- Technology/Process/Product Transfer
- CMC Development
- Clinical Trials Material Management
- Validation
- Process & product
- Facilities & equipment
- Analytical and bioanalytical methods
- Compliance Systems Development
- Quality Systems Tracking
- CAPA (i.e. deviations, investigations, etc.)
- Change Control
- Documentation
- Training
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