Services
If you are in the Regulatory part of business here are some areas I can assist.
1
Regulatory Classification
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Assist with ingredient selection
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Evaluate formula
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Determine Regulatory Pathway (e.g., Division 1 vs 8, OTC vs NHP)
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Provide available options regarding requirements, timelines & costs
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Clearly identify risks/opportunities
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Evaluate ingredients as per FDR & CEPA
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Consult with Health Canada if needed
2
Marketing Authorizations
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Develop PSM package and lead PSM
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Prepare or adapt CTD & Ensure Health Canada’s requirements are included
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Perform systematic literature reviews
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Negotiate approvals with Health Canada
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Liaison with manufacturing sites and commercial teams
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Develop Product Monograph and other labelling components as per PLL
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Research and develop Safety, Efficacy and Quality Summary Reports for Class III NHPs
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Facilitate the registration of foreign vendors and manufacturers
3
Submission Types
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Rx & OTCs
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NDS (Traditional, Hybrid, SRTD), SNDS, ANDS, CTA, DIN, LS
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Rx to OTC Switch
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NPN
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Class I, II, III
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Cosmetic Notification
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Medical Device
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DEL
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SL
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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
Life Cycle Management
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Evaluate changes for Division 8, Division 1 and NHPs
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Develop rational to support strategy
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Compile submissions if required
5
Due Diligence
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Provide Regulatory expert opinion
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Evaluate compliance of products
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Assess Regulatory landscape and identify relevant precedents
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Outline Regulatory requirements for buying or selling products
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Compile submissions if required
6
Training
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Contact me about your needs and I can tailor interactive presentations for your teams such as
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Regulatory 101 for sales and marketing
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PV requirements Drugs vs NHPs
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Labelling Requirements
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7
Scheduling
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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