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Regulatory Submissions

Regulatory Submissions

Plunkett Consulting Group have prepared and submitted a large variety of regulatory applications, including:

  • New chemical or biological medicines
  • Generic applications
  • Device/IVD Inclusion Applications
  • Orphan Drug Designations (ODDs)
  • Investigational New Drug (IND) applications
  • Investigational Device Exemption (IDE) applications
  • Quality or Clinical variations
  • Self-assessable notifications
  • Annual Reports
  • Clinical Trial Notifications

Plunkett Consulting Group have developed various templates to prepared documents in accordance with ICH Common Technical Document (CTD) for medicine application and the IMDRF Technical File formats.


Regulatory Affairs