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    Services for GCC Countries

Regulatory And Product Registration Services for GCC Countries

We are very much honored to offer services to our esteem clients to provide complete GCC Regulatory Services.
Contact us Raised Pharma Scientific Inc. at +1 (716)-777-4800 or info@raisedpharma.com.

Our expert's team members have many years of experience working with GCC Regulatory bodies for Pharma & Nutraceutical Industries. We are honored to offer services to our esteem clients to provide complete GCC Regulatory Services from CTD/eCTD preparation to filing for INDs, NDAs, ANDAs, Prescription (Rx) to over-the-counter (OTC) switch submissions & responding to regulatory concerns or questions which may have originated from Regulatory Authorities and Warning Letters.

We have expertise in following:

  • Product development consultation, plans & risk assessment Prepare & compile five prescribed CTD/eCTD modules
  • IND preparation & Pre-IND to Pre-NDA
  • NDA & ANDA preparations and filing, including CMC and other sections
  • Post-approval support, including support during PAI
  • Orphan drug designation applications & annual support for APR
  • Lifecycle management of product from design to commercialization
  • Electronic submission services

    • Registration by market

    Requirements differ significantly between markets. We have written a detailed guide for each:

    • Saudi Arabia — SFDA — the Food Sector versus Drug Sector classification fork, and why capsule and tablet supplements need pharmaceutical GMP.
    • United Arab Emirates — EDE — the 2025 transfer from MOHAP to the Emirates Drug Establishment, and why municipal registration covers only one emirate.
    • Qatar — MOPH — why Qatar regulates supplements as pharmaceuticals, and the prohibited-substance certificate.
    • Oman — Ministry of Health — mandatory eCTD, Zone IV stability, and the GMP inspection waiver that recognises Health Canada.
    • Kuwait — Ministry of Health — the December 2025 overhaul, and the prior-marketing rule that may block a Canada-only product.
    • Bahrain — NHRA — the two-regulator split, and the one-year origin-market requirement.

    Outside the Gulf: United States (FDA) · Canada (Health Canada)

    We can also advise on whether the GCC centralised procedure suits your market plan. Talk to us.