Regulatory Submissions

Regulatory Submissions

Accelagen 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

Accelagen 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