Strategic Regulatory Partner for Success in Egypt

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

Greetings from
Freyr Egypt

Obtaining market approvals in Egypt would require compliance with the regulations of Central Administration of Pharmaceutical Affairs (CAPA), a division of the Egyptian Ministry of Health. To navigate through the registration and approval procedures, manufacturers should require an authorized representative in the region besides being updated with the region’s Regulatory requirements.

Freyr’s Regulatory consulting for Egypt includes strategic advice on Regulatory submissions for:

Industries We Serve in Egypt

Egypt’s burgeoning demand for medicinal products due to demographic growth and urbanization makes it one of the top markets in Middle East and Africa. All drug products are required to be approved by the Egyptian Drug Authority before distribution or marketing in the country. From decoding the Regulatory framework to aligning with the Regulatory requirements, being compliant with Egyptian Drug Authority might be a tedious task for new market entrants. Added to that, eCTD conversions, Active Pharmaceutical Ingredient designs and other Regulatory processes might require a special attention in order to adhere to the stringent regulations.

Freyr Offerings

  • Strategic Regulatory Consulting
  • Health Authority interactions
  • Registration and license management services
  • Dossier management
  • End-to-end Regulatory submissions
  • Regulatory labeling and artwork services
  • MOH follow-up

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with Ministry of Health
  • Expert Regulatory team with proven track records
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines

Looking for Regulatory Support in Egypt

Contact us now for Expert Guidance and Support