To appropriately manufacture a pharmaceutical or biologic specific manufacturing processes, product characteristics, and product testing must be defined in order to ensure that the product is safe, effective and consistent between batches. 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:
Raw material selection and characterization
Pre-formulations (chemical/physical properties testing and evaluations)
Formulations (chemical/physical properties testing and evaluations)
Methods development and validation
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