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 CMC services include:
- Review of CMC documentation and gap analysis
- Clinical supply planning and management
- Advice on selecting and managing CDMOs
- Identification and acquisition of data that will be necessary or advantageous for smooth discussions with the FDA
- Preparation of CMC dossiers for clinical trial applications (e.g. INDs), marketing submissions (e.g. NDAs and BLAs), amendments, annual reports, and meetings with regulatory agencies
- Identification of CMC issues to be addressed in regulatory meetings
