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Regulatory Affairs

European Medicines Agency (EMA) Services

Aleon stands ready to support your drug development and approval in the EU.

Meetings with EMA and Local Authorities

  • Scientific Advice Meetings
  • Meetings with CHMP
  • Pre-MAA Meetings

Regulatory and Medical Writing

  • Investigational Medicinal Product Dossier (IMPD)
  • Investigator’s Brochure (IB)
  • Clinical Protocol
  • Informed Consent Form
  • Pediatric investigation plans (PIP)
  • MAA

ODDs and Expedited Programs

  • Orphan Drug Designations
  • Accelerated Assessment
  • Exceptional Circumstances
  • Conditional Marketing Authorization
EMA development process diagram