Regulatory

Regulatory services

A number of regulatory services are provided within the nonclinical and clinical space:

  • Regulatory strategies
  • Help and guidance on regulatory and ethics submissions
  • Preparation and/or review of regulatory dossiers including:
    • IMPDs, INDs, NDAs, MAAs, Fast Track dossiers
    • Orphan Medicinal Product and Orphan Drug Application
  • Preparation, meeting and follow-up with Regulatory Authorities
  • Preparation and/or review of essential documents:
    • For clinical trial management and monitoring
    • For risk assessments and pharmacovigilance