CMC

CMC

 

 

Kinexum's CMC services include:   

  • Development and implementation of CMC concepts for Clinical Trials Applications (INDs) and Marketing Submissions (NDAs)
  • 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 and Drug Product  Selection of Contract Manufacturing organizations/companies        
  • Clinical supplies planning and management         
  • Preparation of regulatory CMC dossiers for Clinical Trials Applications, regulatory advice meetings,
  • Marketing Applications, variations, annual reports, information amendments and Drug Master Files
  • Identification of CMC issues to be addressed inn regulatory meetings, and preparation of briefing materials, and appropriate CMC responses in any stage of the regulatory process.

Services