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Chemistry, Manufacturing and Controls Consulting Services

Ensure your chemistry, manufacturing and controls documentation is complete and tells the right story

Areas of expertise

CMC services

  • CMC documentation (Common Technical Document [CTD] module 3) for drug substances and drug products
  • Product development reports
  • Protocols, such as method validation, process validation and comparability
  • Drug Master Files (DMFs) for the United States, Canada, Europe and other regions, including serving as US Agent

  • Analytical method development and validation (including vendor selection, qualification and oversight)
  • Formulation and process development, manufacturing and process validation (including vendor selection, qualification and oversight)
  • Management of clinical trial material production

  • Development of global regulatory strategies
  • Design and management of active pharmaceutical ingredient (API) and drug product (finished formulation) development plans
  • Quality assurance guidance relating to pre- and post-approval CMC changes
  • Guidance on FDA and global regulatory requirements, regulations and guidances
  • Development of quality assurance programs, including quality systems and standard operations procedures (SOPs)
  • Post-approval support (such as annual reports and prior approval supplements)
  • Due diligence reviews of development programs, marketing applications and manufacturing sites
  • Management of registered information for global products 

US Agent services

Beth L. Minter

Beth L. Minter