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If you are in the Commercial part of business here are some areas I can assist.


Product Assessment

  • Assist with ingredient selection

  • Evaluate formula

  • Determine Regulatory Pathway, requirements, timelines & costs

  • Provide potential options based on submission costs, timing and product’s claims

  • Clearly identify risks/opportunities

  • Evaluate ingredients for safety and efficacy

  • Consult with Health Canada if needed


Marketing Approvals

  • Substantiate health and non-health claims

  • Develop rationales for combinations

  • Provide scientific and medical writing for submissions

  • Develop content for labelling that includes unique selling points and minimized text to reduce extra packaging costs

  • Negotiate with Health Canada

  • Lead meetings with Health Canada

  • Compile all submissions content

  • Facilitate the registration of foreign vendors and manufacturers 


Rx to OTC Switch

  • Develop individualized Regulatory strategy since each “Switch” is unique 

  • Work with your team and Health Canada to develop the right approach 

  • Design label comprehension that meets Health Canada’s requirements

  • Develop and write consultation package for Health Canada

  • Lead Consultation meeting with Health Canada

  • Compile submission


Promotional Activities

  • Identify & defend strongest advertising positions

  • Provide recommendations based on federal and provincial requirements

  • Review & make recommendations for media directed to consumers or health professionals 

  • Negotiate approval, if needed, with Health Canada’s Advertising Preclearance Agencies (e.g., Ad Standards, PAAB)


Changes to Products

  • Evaluates manufacturing or labelling changes and determine if submission is required

  • Compile and file submissions


Mergers & Acquisitions

  • Provide Regulatory expert opinion

  • Evaluate compliance of products

  • Outline Regulatory requirements for buying or selling products


Location of Sales

  • Provide competitor landscape

  • Assess possibility of changing location of sales (e.g., BTC to pharmacy to any retail out)

  • Outline requirements for submission to change location of sales

  • I develop unique content to help in a successful approval

  • Compile & File submission

  • Lead meeting to change location of sales

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