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US Regulatory Services

At MS Remedies Inc. we have many years of experience working with FDA for regulated Pharma and Bio-Pharma industries. We take pride to serve your organization to provide complete US FDA Regulatory Services from submission and filing for INDs, NDAs, BLAs and ANDAs to address any concerns or questions which may have originated from FDA Audits such as 483s and Warning Letters.

Please contact MS Remedies Inc. at +1-647-229-7236 or info@MSRemed.com

At MS Remedies Inc. we provide full service to your organization on handling any complex matter with US FDA which may have originated from Inspection, 483s or Warning Letters, we also provide expertise to complete all types of submission and filing for INDs, NDAs, BLAs and ANDAs.

We have expertise in following:

  • Regulatory consulting to have strategic position (we help create Strategic Position Papers)
  • IND preparation & Pre-IND to Pre-NDA
  • NDA, BLA & ANDA preparations and filing, including CMC and other sections
  • Post-approval support, including support during PAI
  • Agency liaison & negotiation
  • Orphan drug designation applications & annual support for APR
  • Lifecycle management of product from design to commercialization
  • Review of promotional material
  • Electronic submission services

To complement to our regulatory services, we provide complete strategic product development consulting, tactical and strategic development plans, development risk assessment and outsourcing. We do cover Technical Transfer to Process Validation. The entire services offered by MS Remedies Inc. provide you one stop solution, where our team members work with your organization to give you extra needed strength.

Please contact MS Remedies Inc. at +1-647-229-7236 or info@MSRemed.com