CMC – Chemistry, Manufacturing and Controls
To ensure that pharmaceuticals are safe, effective and consistent between batches, different methods such as manufacturing processes, product characteristics, and product testing must be defined. These activities are known as CMC – Chemistry, Manufacturing and Control.
Select, audit and manage vendors and service providers and be accountable for client timelines, budgets and technical support.
Our 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 invaluable strategic guidance and CMC development services.
Our network of contract manufacturing organizations (CMOs) allows us to identify the most suitable service providers for your compound and dosage form and ensure optimal performance within your time and budget parameters. Throughout the process, our experts advise on formulation and design, handle site inspection/monitoring, design/review protocols and identify the best method validation strategy to ensure compliance with FDA and ICH guidelines — a critical step for first-cycle review.
Our CMC services include:
- 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 testing
- Manufacturing and release of clinical batches
- Packaging and labeling of clinical supplies
- Container/closure systems testing and evaluations
- Stability protocols, specifications, tests and results