Overview

Evolving Government healthcare initiatives and quick market expansion establishes positive signs for foreign medicinal product and medical device manufacturers to invest in the Kingdom of Morocco. Under the Ministry of Health (Ministère de la santé, MoH), the Moroccan government regulates the healthcare system inclusive of pharmaceuticals and medical devices. Though Morocco recognizes the certifications from the other reputed Health Authorities, which may ease out some of the Regulatory procedures for manufacturers, navigating through the local Regulatory reforms and activities might require an expert market know-how.

Leveraging uninterrupted Regulatory knowledge about the Moroccan Regulatory regime, Freyr assists manufacturers for timely registrations and market authorizations. Freyr is capable to provide Regulatory services in Morocco for:

  • Medical Devices
  • Drugs (NCE , Generics)
  • Bio Tech (Bio similars, Vaccines)
  • Oncology
  • Cosmetics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Market Access licensing
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Marketing Authorization Applications, Post Marketing Maintenance
  • Regulatory Publishing and Submissions
  • CMC ,Clinical variation and Renewal of MA
  • Labelling expertise and approval
  • Value Proposition Development and Target Product Profile Testing

Freyr Advantages

  • Strategic local health authority contacts – with Morocco MOH
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines