Services
If you are in the Commercial part of business here are some areas I can assist.
1
Product Assessment
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Assist with ingredient selection
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Evaluate formula
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Determine Regulatory Pathway, requirements, timelines & costs
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Provide potential options based on submission costs, timing and product’s claims
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Clearly identify risks/opportunities
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Evaluate ingredients for safety and efficacy
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Consult with Health Canada if needed
2
Marketing Approvals
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Substantiate health and non-health claims
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Develop rationales for combinations
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Provide scientific and medical writing for submissions
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Develop content for labelling that includes unique selling points and minimized text to reduce extra packaging costs
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Negotiate with Health Canada
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Lead meetings with Health Canada
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Compile all submissions content
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Facilitate the registration of foreign vendors and manufacturers
3
Rx to OTC Switch
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Develop individualized Regulatory strategy since each “Switch” is unique
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Work with your team and Health Canada to develop the right approach
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Design label comprehension that meets Health Canada’s requirements
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Develop and write consultation package for Health Canada
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Lead Consultation meeting with Health Canada
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Compile submission
4
Promotional Activities
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Identify & defend strongest advertising positions
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Provide recommendations based on federal and provincial requirements
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Review & make recommendations for media directed to consumers or health professionals
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Negotiate approval, if needed, with Health Canada’s Advertising Preclearance Agencies (e.g., Ad Standards, PAAB)
5
Changes to Products
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Evaluates manufacturing or labelling changes and determine if submission is required
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Compile and file submissions
6
Mergers & Acquisitions
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Provide Regulatory expert opinion
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Evaluate compliance of products
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Outline Regulatory requirements for buying or selling products
7
Location of Sales
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Provide competitor landscape
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Assess possibility of changing location of sales (e.g., BTC to pharmacy to any retail out)
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Outline requirements for submission to change location of sales
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I develop unique content to help in a successful approval
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Compile & File submission
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Lead meeting to change location of sales