Chemistry Manufacturing and Controls

Optimizing synthetic routes, formulation characteristics, manufacturing processes and controls, supply and other elements of Chemistry, Manufacturing and Controls have strategic consequences to your product development, budget and timeline. Kinexum specialists can guide you through planning and execution, including selecting and managing CDMOs and commissioning data that will be necessary or advantageous for smooth discussions with FDA, including:   

  • Development and implementation of CMC concepts for Clinical Trials Applications (e.g., INDs) and Marketing Submissions (e.g. NDAs, BLAs) 
  • Review of CMC documentation, gap analysis, and recommendations for generating approvable processes, methods, data and documentation 
  • Evaluation of proposed manufacture and quality control of API, Drug Product, biologics manufacturing, etc.   
  • Selection of Contract Manufacturing organizations/companies         
  • Clinical supplies planning and management         
  • Preparation of regulatory CMC dossiers for Clinical Trials Applications and  regulatory advice meetings, 
  • Marketing Applications, variations, annual reports, information amendments and Drug Master Files 
  • Identification of CMC issues to be addressed in regulatory meetings, and preparation of briefing materials, and appropriate CMC responses in any stage of the regulatory process.