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Camargo’s early involvement in the drug development process saves you substantial time and money. From API and formulation sourcing to manufacturing, scale-up and packaging, we provide you with access to invaluable strategic guidance and management services.
Our solid network of contract manufacturers allows us to identify the most suitable service providers for a given compound and assures you of optimal performance within your time and budget parameters. Throughout the process, Camargo experts advise on formulation and design, handle site inspection and monitoring, design and review protocols, and identify the best methods validation strategy to insure meeting FDA and ICH guidelines — a critical step to ensure first-cycle review.
API
- CMO sourcing
- Specifications and test methods, including:
- Methods validation
- Evaluation of process impurities
- Stability testing and results analysis
Clinical Trial Materials
CMO selection and contracting
CMO management and technical direction
Formulation oversight
- Raw material selection and characterization
- Pre-formulations (chemical/physical properties testing and evaluations)
- Formulations (chemical/physical properties testing and evaluations)
- Methods development and validation
- Impurity profiling
- Release specifications and testin
Manufacturing and release of clinical batches
Packaging and labeling of clinical supplies
Container/closure systems testing and evaluations
Stability protocols, specifications, tests and results
Audit Services
- Address regulatory/compliance challenges and requirements
- Customized to client need
- Comprehensive expertise that meets or exceeds all qualifications criteria
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