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Regulatory Affairs Consulting

By Alpex Pharma

Regulatory Affairs Consulting alpex

  • Regulatory support of:
    Formulation Development
    Analytical Testing
    Scale up
    Clinical Packaging

    alpex
  • Development, assembly and critique of CMC submission for :
    CTD
    CMC
    IND
    ANDA

  • Preparation of DMF
  • Preparation of the investigation brochure for clinical testing