REGULATORY STRATEGY & MARKET ACCESS
PATHWAY CLARITY
Determine the appropriate regulatory and product classification before development advances.
MARKET READINESS
Identify formula, evidence, labeling, and documentation requirements for each intended market.
COMMERCIAL ALIGNMENT
Connect regulatory decisions with manufacturing, positioning, distribution, and launch strategy.
CONNECTED PRODUCT DEVELOPMENT
CONCEPT TO MARKET LAUNCH
Concept
Formulation
Prototype & Samples
Testing & Quality
Packaging & Labeling
Manufacturing
Regulatory Documentation
Amazon & Retail Readiness
Market Launch
For brands planning to sell through Amazon or major retail channels, marketplace preparation should begin during product development — not after manufacturing is complete.
REGULATORY READY
Formula, claims, evidence, documentation, and label requirements are considered before launch.
MANUFACTURING READY
Specifications, testing, packaging, supplier information, and production requirements are aligned before scale-up.
MARKETPLACE READY
Technical and regulatory documentation is organized to support retailer, distributor, Amazon, and other e-commerce compliance requests.
The goal is not simply to develop a product. It is to develop a product that is ready for the market it is intended to enter.
CANADA / HEALTH CANADA
Kompete supports the full Natural Health Product regulatory lifecycle in Canada, from early formulation review and product classification through Product Licence Applications, supporting documentation, label compliance, commercialization, and post-licensing changes.
Our regulatory team can assess products already in development as well as existing licensed products that require formula, claim, brand, label, or ingredient changes.
FORMULATION COMPLIANCE REVIEW
Review medicinal and non-medicinal ingredients, forms and sources, dosages, combinations, routes of administration, recommended uses, cautions, contraindications, and applicable monographs. Where a formula does not align with the intended pathway, Kompete can recommend practical adjustments or reformulation strategies before submission.
PRODUCT LICENCE APPLICATIONS
Preparation and management of NPN and Product Licence Applications across Class I, Class II, and Class III pathways, including technical documentation, evidence packages, label text, and regulatory correspondence.
EVIDENCE DEVELOPMENT
Scientific literature reviews, safety and efficacy evidence, traditional evidence where applicable, claim substantiation, evidence-gap identification, and preparation of concise regulatory summaries.
FINISHED PRODUCT SPECIFICATIONS
Develop and maintain FPS covering identity, potency, purity, microbiological requirements, contaminant limits, testing methods or criteria, acceptance criteria, and shelf-life-related quality expectations.
LABEL COMPLIANCE
Review product name, recommended use, dose, duration, risk statements, medicinal and non-medicinal ingredients, NPN presentation, bilingual requirements, net quantity, company information, claims, and supporting regulatory text.
POST-LICENSING CHANGES
Assess and manage brand-name, medicinal or non-medicinal ingredient, supplier or source, dosage, claim, label, dosage-form, and formulation changes. Kompete determines the appropriate regulatory mechanism—amendment, notification, or a new application—based on the nature of the proposed change.
SITE LICENSING & IMPORTATION
Site licence strategy, importing into Canada, foreign manufacturing documentation, GMP evidence, quality documentation, importer requirements, and cross-border manufacturing coordination.
A structured path from formula to licence.
01
CLASSIFY
Determine the product category and likely NHP application pathway.
02
REVIEW THE FORMULA
Assess ingredients, dosage, claims, monographs, and restrictions.
03
ADJUST WHERE REQUIRED
Make practical formulation or positioning changes where gaps are identified.
04
BUILD THE EVIDENCE
Collect and organize scientific and regulatory support for the product.
05
PREPARE THE FILE
Prepare the PLA, technical documentation, FPS, label text, and supporting materials.
06
SUBMIT
Prepare and file the regulatory submission.
07
RESPOND
Support Health Canada questions, information requests, and deficiencies.
08
LICENCE & COMMERCIALIZE
Support final label readiness and product launch.
09
MAINTAIN
Support amendments, notifications, label, brand, and ingredient changes, and ongoing compliance.
Products manufactured in the United States, Europe, Asia, or other jurisdictions often require additional regulatory and quality coordination before commercialization in Canada. Kompete connects NPN requirements with formulation, manufacturing, testing, documentation, labeling, importing, and supplier requirements so the product moves as one coordinated project.
U.S. PRODUCT CLASSIFICATION
PREMARKET APPROVAL / APPLICATION
Certain regulated products require an FDA application and authorization before commercial marketing.
NEW DRUGS
NDA pathway
GENERIC DRUGS
ANDA pathway
CLASS III MEDICAL DEVICES
PMA generally applies
CERTAIN FOOD & COLOR ADDITIVES
Premarket authorization may be required
CLEARANCE / NOTIFICATION / OTHER PREMARKET ACTION
Some products do not follow an “approval” pathway but still require a regulatory action before market entry.
CLASS II MEDICAL DEVICES
Many require 510(k) clearance
NEW DIETARY INGREDIENTS
NDI notification may apply
SELECT MEDICAL DEVICES
De Novo or other applicable pathways
NO INDIVIDUAL PRODUCT PRE-APPROVAL
Several major FDA-regulated categories can generally enter the market without FDA approving each finished product first, provided all applicable requirements are met.
DIETARY SUPPLEMENTS
CONVENTIONAL FOODS
COSMETICS
Except applicable color-additive requirements and other regulatory obligations
OTC MONOGRAPH DRUGS
When marketed in conformity with the applicable OTC monograph and other requirements
MOST CLASS I AND SOME CLASS II DEVICES
Where applicable exemptions apply
The absence of FDA premarket approval does not mean the absence of FDA regulation.
Dietary supplement
Conventional food
Functional food
Medical food
Cosmetic
OTC drug
Prescription or new drug concept
Medical device
Food ingredient
Color additive
Other FDA-regulated product
CLASSIFY
Determine the applicable FDA category and regulatory pathway.
ASSESS
Review formula, ingredients, claims, labeling, and intended use against the selected pathway.
ADAPT
Recommend formulation, claim, label, or documentation changes where compliance gaps exist.
PREPARE
Build the technical and regulatory materials required for commercialization or submission.
Formula compliance review
Supplement Facts or Nutrition Facts review
Claims assessment
Technical label review
Ingredient documentation
Finished-product specifications
COA and testing review
GMP documentation
Supplier documentation
Product identity documentation
Safety and scientific substantiation
Retailer compliance questionnaires
Amazon documentation readiness
Corrective documentation where deficiencies are identified
Where an existing product is flagged by a retailer or marketplace, Kompete can review the requested documentation, identify the underlying compliance issue, coordinate technical corrections, and help prepare an appropriate response package.
AUSTRALIA / TGA
Australia applies its own ingredient, indication, evidence, manufacturing, labeling, advertising, and post-market requirements to complementary medicines. Kompete helps assess the intended product early and determine what may need to change before entering the Australian market.
INGREDIENTS
Permitted ingredient assessment, ingredient restrictions and forms, dosage considerations, excipient considerations, and pathway eligibility.
INDICATIONS & EVIDENCE
Permitted indications, claim strategy, evidence requirements, scientific substantiation, safety support, and limitations on therapeutic positioning.
REGULATORY PATHWAY
Assess the appropriate category and route, including listed medicines, assessed listed medicines where applicable, registered complementary medicines where applicable, and other relevant product classifications.
ARTG / MARKET ENTRY PREPARATION
Technical documentation, formulation information, sponsor coordination, manufacturer documentation, submission readiness, and market-entry planning.
LABELING, ADVERTISING & POST-MARKET
Label compliance, required statements, indications, claims, warnings, advertising considerations, stability, specifications, product changes, and ongoing post-market obligations.
A clear pathway into the Australian market.
CLASSIFY
SCREEN INGREDIENTS
REVIEW INDICATIONS
BUILD EVIDENCE
PREPARE TECHNICAL FILE
LIST / REGISTER
LABEL & COMMERCIALIZE
POST-MARKET MAINTENANCE
SPORTS NUTRITION / THIRD-PARTY CERTIFICATION
FORMULA SCREENING
Assess the formulation and individual ingredients for certification considerations and prohibited-substance risk.
SUPPLIER DOCUMENTATION
Review supplier specifications, certificates, testing documentation, and ingredient traceability.
LABEL & CLAIM REVIEW
Confirm that declared ingredients, claims, and label presentation align with the actual formulation and certification objectives.
MANUFACTURING READINESS
Review relevant GMP, manufacturing, quality-system, and facility documentation before certification.
TESTING STRATEGY
Coordinate appropriate finished-product testing and identify documentation or analytical gaps before formal certification testing.
CERTIFICATION PROJECT MANAGEMENT
Coordinate technical workstreams between the brand, manufacturer, ingredient suppliers, laboratories, and certification organizations.
NSF certification readiness process
01
FORMULA SCREEN
02
SUPPLIER REVIEW
03
LABEL REVIEW
04
MANUFACTURING / GMP REVIEW
05
DOCUMENTATION PACKAGE
06
PRODUCT TESTING
07
CERTIFICATION COORDINATION
08
ONGOING MONITORING
REGULATORY DIMENSION
CANADA / NPN
UNITED STATES / FDA
EUROPEAN UNION
AUSTRALIA / TGA
Product classification
NHP, food, cosmetic, drug, or device classification.
Category depends on intended use, composition, and claims.
Food supplement, food, cosmetic, medicine, or device route.
Complementary medicine or other applicable category.
Ingredient review
Medicinal, non-medicinal, source, dose, and monograph fit.
Identity, status, restrictions, and category-specific requirements.
Union and member-state rules may both affect acceptability.
Permitted ingredient, form, restriction, and dose screening.
Formula compliance
Alignment with the chosen NHP licence pathway.
Requirements vary materially by product category.
Market-specific adaptation may be required.
Formula must fit the selected TGA pathway.
Claims
Recommended uses and risk text must align with the licence.
Claim type changes the compliance framework.
Authorized and national rules constrain positioning.
Permitted indications and evidence level shape claims.
Scientific evidence
Monograph, scientific, or traditional support as applicable.
Evidence expectations depend on claim and category.
Safety and claim substantiation requirements differ by route.
Evidence level must support indications and pathway.
Label requirements
Bilingual NHP label content and NPN presentation.
Category-specific principal display and information panels.
EU and member-state language and presentation rules.
Required statements, indications, warnings, and presentation.
Submission / notification
Product Licence Application before sale of an NHP.
Approval, clearance, notification, listing, or none at product level.
Notification or authorization varies by category and country.
ARTG listing or registration route as applicable.
Manufacturing requirements
Site licensing, quality evidence, and applicable GMP.
Category-specific registration and manufacturing controls.
Manufacturing standards depend on category and route.
Manufacturer evidence and applicable GMP expectations.
Importer / sponsor requirements
Canadian licence-holder and importer responsibilities.
U.S. agent or importer obligations may apply.
Responsible person or importer model varies by category.
Australian sponsor responsibilities are central to market entry.
Post-market changes
Mechanism depends on the nature and significance of the change.
Change controls differ by category and regulatory status.
Notifications and updates vary by route and member state.
ARTG, label, evidence, and sponsor obligations continue.
Kompete can compare the same formulation across multiple jurisdictions and identify where a common global product can be maintained and where market-specific changes are required.
01
CLASSIFY
Define the product category, intended claims, dosage form, and applicable regulatory pathway.
02
ASSESS
Review the formula, ingredients, evidence, specifications, labeling, and market-specific requirements.
03
PREPARE
Build the dossier, technical documentation, claims framework, and submission-ready materials.
04
ENTER
Support submission, authority communications, launch preparation, and ongoing compliance.
Product classification assessment
Regulatory feasibility and risk review
Ingredient and dosage compliance matrix
Market-entry strategy and launch sequence
Dossier and submission documentation
Claims and label review
Evidence-gap analysis
Regulatory authority response support
Market adaptation recommendations
Cross-functional commercialization roadmap
Emerging supplement and wellness brands
Established nutraceutical companies
Functional food developers
Cosmetic and personal-care brands
Pet health product companies
Ingredient suppliers
Contract manufacturers
International brands entering Canada, the U.S., Europe, or Australia
Kompete can assess your product, intended claims, formula, and target markets to identify the clearest route forward.
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