REGULATORY & MARKET ACCESS
Regulatory Strategy & Market Access
Clear pathways for product classification, dossier preparation and market-entry planning.
FROM FORMULA TO MARKET
Some products do not fit in one box.
A formula can be a natural health product in Canada, a dietary supplement in the United States, a food supplement in Europe, a complementary medicine in Australia, or a drug, depending on its format, its dose and what you say about it. We work on the products where that answer is not obvious, and we settle it before the formula is locked.
CAPABILITIES
Scientific expertise. From concept to market.
Formulation, regulatory and commercial support to help health and wellness products move from development to market.
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Regulatory
Regulatory Strategy & Market Access
Regulatory strategy, submissions and market-entry support.
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Formulation
Formulation & Sensory Development
Formula development, novel ingredients and sensory refinement.
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Analytical
Analytical Testing & Stability Support
Third-party lab coordination, stability planning and CoA review.
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Manufacturing
Manufacturing, Sourcing & Distribution
Manufacturer sourcing, ingredient brokerage and selected distribution.
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Advisory
Advanced Delivery & Scientific Advisory
Scientific guidance on novel actives. delivery systems and formats.
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Concept to compliant market
1
Discover
Understand your goals and market landscape.
2
Formulate
Develop optimal formulations and product concepts.
3
Validate
Conduct testing and verify quality and claims.
4
Submit
Prepare and submit regulatory dossiers with confidence.
5
Manufacture
Oversee GMP production and ensure supply readiness.
6
Launch
Execute go-to-market and commercial success.
GLOBAL MARKET ACCESS
Take your formula into new markets.
Understand the product classification, ingredient requirements and labelling needed for your next launch.
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CACanada01 / 07
Natural health products
A clear plan for Canada.
Bring your formula, supporting evidence and product presentation together for the Canadian market.
HOW WE CAN HELP
- 01NPN application support
- 02Ingredient & dose review
- 03Bilingual label & claims review
Formulation & product development
Find the right format.
From familiar essentials to new delivery concepts. Explore the possibilities for your next product.
Everyday6 formats to explore
Gummies
A gummy people want to take.
Balance active loading, flavour and texture within a realistic serving size. Build the sensory experience into the formulation brief.
Product possibilities
- Vitamin gummies
- Mineral gummies
- Botanical gummies
Before we begin
A clearer path forward.
Practical answers before your next product takes shape.
Yes. We can compare options against your ingredients, serving size, audience, target market and manufacturing needs.
We can review an existing formula, identify practical gaps and help refine the formulation brief for your intended market.
Yes. We can work with your manufacturer to align the formula, specifications and supporting documentation with the agreed project scope.
We begin with feasibility: the ingredients, dose, user experience, target market and available manufacturing capabilities. This helps define a realistic development path before committing to a format.
REGULATORY
NPN vs. FDA: Key Differences for Nutraceuticals
A comparative guide to regulatory pathways for natural and supplement products.
FORMULATION
Designing Stable, Effective Nutraceutical Formulas
Key considerations for ingredient selection, bioavailability, and product stability.
MARKET STRATEGY
Global Expansion: Building Your Regulatory Roadmap
How to prioritize markets and sequence submissions for efficient global growth.
CASE STUDIES
Pharmaceutical Development
The release result that belonged to a different product
A medicated chewing gum developer believed they had validated release data. The arithmetic said otherwise.
Read the full case study
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Private Label
More than fifty therapeutic areas, each with the formula, testing and regulatory pathway already resolved.
Catalogue spreads
Finished products
Your brand
Your label, bottle, closure and pack size.
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Let’s talk about your product
Tell us what you’re working on.
Have a product idea or a question? Send us a few details and we’ll get back to you within one business day.
Prefer email?
info@kompeteconsulting.com