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Regulatory And Product Registration
Services for GCC Countries

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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(905)-581-8378 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 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 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