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Chemistry, Manufacturing & Controls

Our early involvement in the product development process saves you substantial time and money. From API and formulation sourcing, to manufacturing scale-up and packaging, we provide invaluable strategic insights 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.

CMC Components 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
  • Preapproval inspection preparation and remediation
  • Process optimization and validation
  • Cleaning validation
  • Sterility validation
  • Quality management system development

To learn how you can benefit from our chemistry, manufacturing & controls expertise, Contact Us.