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Services

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

1

Regulatory Classification

  • Assist with ingredient selection

  • Evaluate formula

  • Determine Regulatory Pathway (e.g., Division 1 vs 8, OTC vs NHP)

  • Provide available options regarding requirements, timelines & costs

  • Clearly identify risks/opportunities

  • Evaluate ingredients as per FDR & CEPA

  • Consult with Health Canada if needed

2

Marketing Authorizations

  • Develop PSM package and lead PSM

  • Prepare or adapt CTD & Ensure Health Canada’s requirements are included

  • Perform systematic literature reviews

  • Negotiate approvals with Health Canada

  • Liaison with manufacturing sites and commercial teams

  • Develop Product Monograph and other labelling components as per PLL

  • Research and develop Safety, Efficacy and Quality Summary Reports for Class III NHPs

  • Facilitate the registration of foreign vendors and manufacturers 

3

Submission Types

  • Rx & OTCs

    • NDS (Traditional, Hybrid, SRTD), SNDS, ANDS, CTA, DIN, LS

  • Rx to OTC Switch​

  • NPN 

    • Class I, II, III

  • Cosmetic Notification

  • Medical Device

  • DEL

  • SL

  • 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

4

Life Cycle Management

  • Evaluate changes for Division 8, Division 1 and NHPs

  • Develop rational to support strategy

  • Compile submissions if required

5

Due Diligence

  • Provide Regulatory expert opinion

  • Evaluate compliance of products

  • Assess Regulatory landscape and identify relevant precedents

  • Outline Regulatory requirements for buying or selling products

  • Compile submissions if required

6

Training

  • Contact me about your needs and I can tailor interactive presentations for your teams such as

    • Regulatory 101 for sales and marketing

    • PV requirements Drugs vs NHPs

    • Labelling Requirements

7

Scheduling

  • 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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