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CLINICAL CMC CONSULTANCY

  • CMO Selection for Drug Product manufacturing

  • Lead Drug Product  transfer from lab to GMP 

  • GMP scale up across the full drug development cycle (Phases I-III) 

  • Lead Drug Product transfer between different sites and companies

  • Protocols and reports writing

  • Batch record review

  • Change control's impact, RCA, deviation handling, CAPA implementation

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