INDIA

DCGI Authorized Agent / In-Country Care Taker

Drugs

• Product Life Cycle Management
• Regulatory Strategy Consulting and Liaison
• Compilation of Dossier / DMF and conversion to e-CTD format
• Liasioning with DCGI for obtaining marketing authorization for new drugs
• Compilation and preparation of submission ready applications
• DCGI approvals
  • New drug approval for the following:
    • Drugs (APIs & Formulation)
    • Biologics (vaccines, rDNA products, blood products etc.)
  • Approval / NOC for clinical trials
• Annual Report
• Query Management
• PSUR writing
• Medical Communication, Training, and 24/7 Call Center
• Conducting Clinical Studies

Devices:

• Regulatory Strategy Consulting and Liaison
• Assistance in getting Import licenses and medical device /IVD registration
• Registration of foreign manufacturing plants
• GxP Audits and Compliance Consulting
• Labeling
• Commercialization
• Post marketing Vigilance studies and Risk Management
• Medical Communication, Training, and 24/7 Call Center
• Conducting Clinical studies