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.

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.

Contact us today to learn more on how you can benefit from our Chemistry, Manufacturing & Controls expertise!