Market Access

MEALIS acts as a Regional Regulatory Support Provider: regional expertise, regional coverage, one hub

  • Provides regulatory support for pharmaceutical (brand, generic and OTC) and medical devices registration across MENA region. Services include: registration requirements preparation, dossier review, eCTD format review, price strategy preparation, file submission, approval follow up and variation submission.
  • Provides import approvals for non-registered products.
  • Provides regulatory advice about requirements, inquiries and decisions