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Chemistry, Manufacturing, and Controls

Chemistry, Manufacturing, and Controls

Chemistry, manufacturing, and controls (CMC) are an essential part of your product development, budget, and timeline. 

Kinexum experts can help you optimize the formulation, synthesis, manufacturing, controls, and related processes required to make your product and supply it to clinical sites.

Our services include:

  • Review of documentation and gap analysis
  • Clinical supply planning and management
  • Advice on selecting and managing CDMOs 
  • Identification and acquisition of necessary data (e.g. batch analysis, stability)
  • Preparation of dossiers for clinical trial applications (e.g. IND), marketing submissions (e.g. NDA, BLA, PMA), amendments, annual reports, and meetings with regulatory agencies
  • Identification of issues to be addressed in regulatory meetings 
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