CMC - Chemistry, Manufacturing, and Control

To ensure that a pharmaceutical is safe, effective and consistent between batches, methods like manufacturing processes, product characteristics, and product testing must be properly defined. These activities are known as Chemistry, Manufacturing and Control (CMC).

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. New chemical entities (NCE) are compounds that emerge from the process of drug discovery. These have promising activity against a particular biological target that is important in disease. Drug development must establish the physicochemical properties of the NCE: its chemical makeup, stability, and solubility. Manufacturers must optimize the process they use to make the chemical so they can scale up from a medicinal chemist producing milligrams, to manufacturing on the kilogram and ton scale. They further examine the product for suitability to package as capsules, tablets, aerosol, intramuscular injectable, subcutaneous injectable, or intravenous formulations. Together, these processes are known as Chemistry, Manufacturing, and Control (CMC).

CMC Development Strategies include:

Drug Product Development

API and Excipient Sourcing
Analytical Development
Analytical Testing and Validation Management
Formulation Development Management
Report Documentation
Analytical and Formulation Vendor Selection and Management
Project Management

Clinical Trial Material

Planning and Oversight of CTM Manufacturing
Oversight of Packaging and Labelling
Management of CTM Inventory and Distribution Logistics

Supply Chain and Manufacturing Strategy

Technology Transfer Planning and Management
Vendor and Facility Selection
Manufacturing Strategy
Manufacturing Process Development and Validation
Process Assessment and Optimization
Manufacturing Scale-Up
Material Sourcing

Quality and Compliance

Gap and Risk Assessments
Technical and Process Auditing
Pre-Approval Inspection Preparation and Remediation
Process Optimization and Validation
Cleaning Validation
Sterility Validation
Quality Management System Development

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.

The C2C Approach

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.