Bridging the Regulatory and Access Strategy

In today's complex global market, a successful product launch isn't just about science—it's about strategy. We specialize in providing a unified approach that seamlessly connects regulatory strategy with your market access and commercial goals.

Navigating Different Regulatory Pathways For Your Health Product

The Global Regulatory Maze: Your Product's Claims vs. Its Path to Market

•A product's intended use and claims directly determine its regulatory classification and the evidence required for approval.

The Regulatory Conundrum: What Pathway to Choose?

The Drug Pathway: The Highest Bar for Entry

•Intended Use & Claims: Products that claim to cure, mitigate, or prevent a disease (e.g., "Hyaluronic Acid heals joint damage").

•Required Evidence: Full, multi-phase human clinical trials. This includes proving both safety and efficacy in a defined patient population.

•Mode of Action (MoA): The product must have a pharmacological, metabolic, or immunological MoA.

•Verdict: This path offers the strongest claims but is a massive investment of time and capital.

The Medical Device & NHP Pathways: The Middle Ground

Medical Device:

•Intended Use & Claims : To achieve a therapeutic purpose through a physical or mechanical mode of action, such as a dermal filler to correct facial wrinkles (e.g. “ Hyaluronic Acid adds volume to correct nasolabial folds”)

•Required Evidence: Demonstrating safety and performance through technical documentation and biocompatibility data.

Natural Health Product (NHP, CA) / Complementary Medicine (AU):

•Intended Use: For low-level health claims, often based on traditional use or pre-existing scientific data (e.g. "Helps support overall skin health.”)

•Required Evidence: Listed as a NHP in Canada. Submission of a dossier to a regulatory body (like Health Canada) with data on safety, quality, and efficacy, which can be a combination of scientific literature and traditional use evidence.

The Cosmetic & Wellness Pathways: The Lowest Regulatory Burden

Cosmetics:

•Intended Use & Claims: For beautifying, cleansing, or altering the appearance (e.g., a serum that visibly plumps skin or reduces the appearance of fine lines).

•Required Evidence: Does not require pre-market approval, but needs a registration. Claims must be supported by scientific substantiation but not allowed to make therapeutic claims about a disease or altering the body's structure or function.

Wellness (US):

•Intended Use & Claims: To promote a healthy lifestyle without any therapeutic purpose (e.g. "Supports your wellness journey”)

•Required Evidence: Not a regulated category. No pre-market approval, and no mandatory registration.

Strategic Choice: The Commercial Trade-Off

There is a direct trade-off between the strength of your claims and the regulatory burden you will face:

•For strong therapeutic claims, the only path is a full drug development program.

•For faster market entry, the best path is to carefully craft low-level claims that fit the cosmetic (non-therapeutic), NHP (general health), or medical device (physical mode of action) categories.

Our Approach:


  • Integrated Strategy: We provide a unified approach that connects your regulatory pathway directly to your market access and commercial goals. We believe that a smart regulatory decision is the foundation for a powerful and profitable market access plan.
  • Early-Stage Insight: We help you identify and mitigate regulatory risks at the earliest stages of product development. By understanding the specific requirements of each market, we help you avoid costly delays and ensure a more efficient path to market.
  • Maximizing Value: We translate your product's approved claims and scientific evidence into a compelling value proposition for payers, healthcare providers, and consumers. The claims you can make directly influence your pricing strategy and potential for reimbursement.


The Power of a Strategic Regulatory Plan:


Every market has its own rules. Our expertise helps you navigate these nuances to find the most viable pathway for your product:

  • For Strong Claims: We guide you through the rigorous and costly process of gaining drug approval.
  • For Faster Market Entry: We help you carefully craft low-level claims that fit into other categories like Natural Health Products or Medical Devices, allowing for a more efficient launch.