Global Regulatory Affairs Services

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Regulatory

Regulatory
  • Draft and review of CTD sections for global submissions
    • Module 2 (2.3.QOS)
    • Module 3 (3.2.S, 3.2.P, 3.2.A and 3.2.R)
    • Review of all “attached” documents associated or submitted with Module 3
  • Paper and/or electronic filing
  • INDs/IMPDs/CTAs and amendments
  • Marketing Application (NDAs, BLAs, MAAs)
  • Variations
    • Major variations (Prior-Approval Submissions, Type II, MAV…)
    • Minor variations (CBE30, Type IA, Type IB, MIV…)
    • Notifications (CBE0, Type IAIN…)
  • Annual reports
  • DMFs/ASMFs
  • Briefing books
  • Meeting with Health Agencies (Preparation, meeting minutes).