REGULATORY AND PRODUCT
REGISTRATION SERVICES FOR USA

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    REGISTRATION SERVICES FOR USA

REGULATORY AND PRODUCT REGISTRATION SERVICES FOR USA

We are very much honored to offer services to our esteem clients to provide complete US 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 US FDA for regulated Pharma & Nutraceutical Industries. We are honored to offer services to our esteem clients to provide complete US FDA 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 FDA Audits such as 483s 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