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Canadian Regulatory Services

At MS Remedies Inc. we have many years of experience working with Health Canada for regulated Pharma and Bio-Pharma industries. We take pride to serve your organization to provide complete Health Canada Regulatory Services from submission and filing for DINs, NDS, SNDS, ANDS, Prescription (Rx) to over-the-counter (OTC) switch submissions. We also help your organization address any concerns or questions which may have originated from Health Canada Audits such as Observation 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 Health Canada which may have originated from Inspection, Observation Letters or Warning Letters, we also provide expertise to complete all types of submission and filing DINs, NDS, SNDS, ANDS, Prescription (Rx) to over-the-counter (OTC) switch submissions.

We have expertise in following:

  • Regulatory consulting to have strategic position (we help create Strategic Position Papers)
  • Clinical trial applications (CTAs)
  • New drug and biologic submissions (NDS, SNDS, ANDS)
  • Prescription (Rx) to over-the-counter (OTC) switch submissions
  • DIN applications and notifiable changes
  • Medical device license applications
  • Natural Health Product (NHP) and food submissions
  • Cosmetics and new substance notifications
  • Regulatory CMC consulting services
  • Post-approval support, including support during Inspection
  • Agency liaison & negotiation
  • Drug establishment licensing, NHP Site Licensing and product release
  • Literature searches
  • Patented Medicine Prices Review Board (PMPRB) reporting
  • Preparation of Health Canada pre-meeting packages

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