Quality Assurance and Regulatory Affairs

  • Preparation and filing of submissions for prescription and non-prescription drugs, biologics, veterinary products & devices
    INDs, NDAs, ANDAs
  • DMFs and PMFs in compliance with current standards;
    Establishment License Applications.
  • Good Laboratory Practice and QA Set-up and management of research laboratories in compliance with industry and government guidelines.
  • Will Assume complete quality control function for companies without QC/QA :
    -.Release products on-time for market.
    -┬ĚComprehensive accurate reporting.
    -Problem solving / recommendations.
    -Complete product traceability.
    -Complete SOPs /SOP manual
  • GMP audits, As per FDA and HPFB, EMA and WHO requirements vendor/supplier audits, policy procedure review and development
  • GMP HPFB, EMA,FDA and W.HO , MOP audits
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