Development Services

Cherokee Pharma provides an extensive range of drug product development services:

  • Formulation and product strategy development
  • Analytical method development, materials and product characterization for pilot and clinical stability
  • Process development, scale-up and transfer to on-site commercial manufacture managed thru a network of preferred CMO's
  • Phase I clinical study, managed thru a network of preferred CRO's
  • Biopharmaceutics, including IVIVC
  • Full project leadership and management

Project Management

At Cherokee, we treat each of our customers uniquely. Customers are assigned dedicated scientists who are responsible for their projects from start to finish, ensuring they remain on target and on time.

Development Capabilities

  • Pre-formulation Characterization
    • Active, excipient, in-process and finished product characterization
  • Formulation
    • Feasibility laboratory
    • Experimental design - formulation/process optimization
    • cGMP area - pilot scale formulation prototype manufacture

Quality Assurance

Cherokee's Quality group holds the responsibility of releasing materials for manufacturing and clients' batch records and undertakes this according to internal standard operating procedures and cGMPs.

Registration Support

Cherokee's management's regulatory experience has successfully assisted a number of companies with various applications to the regulatory authorities in the United States, Europe and Japan.

Cherokee Pharma can provide assistance to its clients with the preparation of New Drug Applications, Abbreviated New Drug Application and updates, Investigational New Drug Applications, Drug Master files and post-marketing supplements.