CMC Development Services

Chemistry, Manufacturing and Controls (CMC) Development Services

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 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, Camargo 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.

The CMC (quality) modules of a regulatory application often are written as stand-alone components of the file. However, if a common thread connects the CMC modules to the nonclinical and clinical modules, the regulatory application becomes a coherent story. It’s not unusual for development programs to undergo a formulation or specification change along the path of preparing a regulatory submission. This can all be managed provided the changes are documented and the impact of the change is evaluated and supported by data. Providing a connection from the old to the new with a data trail is the best way to assure the FDA that the development history of the product is in the application.

The connection from the drug product (all CMC components) to the clinical trial data and the supportive nonclinical data is the heart of the application to the FDA. Camargo ensures this connection is clear and seamless so that the data will speak for your application.

Active Pharmaceutical Ingredient (API)

  • CMO sourcing
  • Specifications and test methods
    • Method validation
    • Evaluation of process impurities
    • Stability testing and results analysis

Clinical Trial Materials

  • 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 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

Audit Services

  • Solutions to address regulatory/compliance challenges and requirements
  • Services customized to your study/program needs
  • Comprehensive expertise that meets or exceeds all qualification criteria
  • CMO evaluation, selection and contracting