Chemistry, Manufacturing and Control - CMC Documentation:

  • QA review of CMC documents like specifications, batch data, development reports and
  • stability reports

  • QA review of the CMC package used in INDs or IMPDs
  • Consultancy in CMC issues
  • Planning of the CMC activities at the CMOs including the Clinical Supplies

 


 

Due Diligence:

 

  • QA review and evaluation of CMC documents available for the Due Diligence process
  • Audit activities with focus on the Due Diligence process


KIBW Concept

 

Target Groups:

Small and Mid Cap Companies (Pharma and Biotech)