Clinical Manufacturing and CMC Support

CLINICAL MANUFACTURING
CMS SUPPORT

• Development reports 
• Process descriptions
• Validation support
  

QUALITY ASSURANCE/QUALITY CONTROL SUPPORT 

• Technical assessments and audits of CRO and CMOs
• Input into specifications
• Input into stability samples w QC
• Supply HPLC marker compounds via synthesis at CRO
• Deviation, Out-of-spec, investigation Support
  
  

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