Regulatory Affairs

Focus on Quality Training
  • Introduction to Global Regulatory Authorities for pharma and healthcare industries
  • Drug Development Process
  • Clinical Trials and related norms and regulations
  • GMP
  • Other good practices
  • Documentation of drug trials and regulatory filings in:
    • US, EU
    • India, Japan, Canada
    • Australia, South Africa, etc.
  • Quality Assurance and Drug Regulations
  • ICH and WHO guidelines
  • Dossier preparation in CTD format
  • eCTD submissions
  • Healthcare Industry IPR
  • Patents, copyrights and Trademarks
  • Pharma and Healthcare products
    • Marketing, Import and Export regulations
  • Compliance guidelines
  • Health authorityAudits (FDA, MHRA, PMDA, TGA, DCG, etc)
  • Breach reports
  • Industry specific case studies

Contact Us

  •   3rd floor,KFC Building, Opp SBH HO,Gunfoundry, Near Chermas,Abids Hyderabad - 500001, Telangana, INDIA.
  •   +91 40 2323 8040
  •   +91 8099928580/82/79/78/77/76
  • info@technoworldgroup.com