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PRODUCT 
REGULATORY AFFAIRS

First time in market and need a regulatory compliance strategy?

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Evon is a Regulatory Affairs professional specializing in health product governance, representing clients from the natural health, food, and wellness sectors to navigate federal and state product compliance waters internationally. 

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With nearly a decade of experience in the healthcare and health/wellness industries, Evon is your strategic partner to help understand how to bring your product to market within the scientific policy climate. 

SERVICES

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Global Affairs

  • Health Canada: NHPs, supplemented foods, foods

  • US FDA: Dietary supplements, OTC drugs

  • Malaysia NPRA: new ingredient registrations

  • Taiwan & China FDA : health food, food, cosmetics

  • India FSSAI: nutraceutical foods, new herbal ingredients

  • Australia TGA: complementary medicines

Strategic Regulatory Support

  • Classification assessment

  • Product & site compliance gap assessment 

  • Policy & scientific safety evaluation

  • Package labelling compliance

  • Adverse reaction management

  • Annual safety reporting

  • Recall support

  • Representation with regulatory authorities

  • Acting Responsible Person 

Other Technical Services

  • Scientific substantiation

  • Internal compliance team management

  • Product & formulations development

  • Product nutrient analysis

  • Quality program solutions

Whether you need ad hoc regulatory consultation or start-to-finish regulatory management, Evon can help navigate every step of the way with governing authorities and your R&D, quality, and marketing/design teams to make your product submission and launch a success. 

INDUSTRY COLLABORATIONS

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POLICY ENGAGEMENTS

An understanding of the legislative governance of products and its policy trends is incredibly important to help navigate compliance expectations from authorities. My regulatory approach is formed by the belief that public policy environments are shaped through collaborative dialogue between government and industry.  I am either actively working on bridging communications with governing bodies directly and/or via industry associations, and have represented in some way on the following policies:

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Health Canada

  • Self-Care Product Regulatory Framework - Bill C47 (2020-2022)

  • Amendments to the NHP Regulations (2020-2022)

  • NHP Cost Recovery Program (2023)

  • Amendments Concerning the Disclosure of Cosmetic Ingredients (2022) 

  • Amendments to Vanessa's Law (2023)

  • CCCR, 2001Amendments (2023)

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FDA

  • Interim COVID-19 Hand Sanitizer Policy (2020)

  • Modernization of Cosmetics Regulation Act (2022) 

  • Cosmetic GMPs

  • OTC Monograph Drug User Fee Program (OMUFA) (2003)

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California State

  • SB-312 Cosmetic Right to Know Act

  • SB-258 Cleaning Products RTKA

Rest of World

  • India FFSAI - Non-Specified Food & Food Ingredient Regulation (2017)

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