CMC Product Development Services

Clinquest together with our alliances offers CMC product development consultation services for protein, peptide and small molecule products. Our services cover both drug substance and drug product development topics, from preclinical to Phase III programs, including commercial launch.

CMC Product Development Core Services:

  • Provide day-to-day development assistance, troubleshooting, and regular participation on CMC and project teams
  • Assist with strategic planning
  • Coordinate vendor selection
  • Manage the execution of vendor contracts on clients’ behalf
  • Assist with the development of a variety of dosage forms including:
    • Injectables
    • Oral tablets
    • Capsules
    • Powders
  • Provide expertise in ophthalmic, inhaled solutions and powders, and nasally delivered products
  • Provide development guidance for:
    • Pre-formulation
    • Formulation
    • Analytical methods
    • Process development
    • Technical transfer
  • Provide guidance regarding the technical and quality aspects of vendor agreements such as: 
    • Master service agreements
    • Quality agreements
    • Supply agreements