,
Greetings from
Freyr kuwait
With huge share of imports and certainly low volume of local manufacturing, the State of Kuwait portrays a better scope of foreign medical device and medicinal product manufacturers entering the market. While doing so, given the strong Pharma Regulatory structure of Kuwait, foreign manufacturers without a clear-cut market awareness might encounter procedural challenges to obtain licenses, registrations and product approvals from the State of Kuwait Drug and Food Control Administration.
With a dedicated regional delivery center in Dubai, Freyr is focused on navigating the clients throughout the market entry process. Right from providing expert Regulatory consultation on market requirements to defining foolproof Regulatory strategies to fetching out in-time Regulatory procedural support, Freyr’s Regulatory services for Kuwait span across:
- Medical Devices
- Drugs
Medicinal Products Regulatory Support in Kuwait
The Kuwait Drug and Food Control Administration (KDFCA) under the Ministry of Health (MoH) regulates, evaluates, and authorizes medicinal products in Kuwait. Companies must comply with stringent dossier requirements aligned with GCC-DR / ICH standards, meet local GMP expectations, secure pricing approvals, and follow Arabic labeling rules.
We provide end-to-end Regulatory support in Kuwait—including CTD dossier preparation, GCC submission management, pricing guidance, GMP documentation support, Regulatory pathway strategy, and lifecycle management—helping pharmaceutical companies achieve smooth and compliant market entry.
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory Affairs & Regulatory intelligence
- Dossier preparation
- conversion of CTD to eCTD
- Submission, maintenance and regulatory preparations as per GCC guidelines
Freyr Advantages
- 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