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Global Regulatory Strategy
We build regulatory strategy into the product from the very beginning, not as an afterthought. This ensures your formulation is both effective and legally marketable in your target regions, giving you confidence from development through to launch.
01
Claims Strategy & Positioning
Claims drive consumer trust and marketing performance, but they must be legally substantiated and precisely structured.
Claim Eligibility Alignment
We assess your product against authorised health, nutrition, and structure function claim frameworks in your target market. Every ingredient and dose is evaluated to ensure it supports permitted messaging, helping your product stand out without regulatory risk.
Structure & Function
We ensure your claims stay within allowable functional language, avoiding inadvertent medicinal claims that could trigger enforcement or misbranding issues.
Evidence Based Substantiation
Our team reviews peer-reviewed studies, clinical trials, and safety data to document the scientific justification behind your claims, building a defensible evidence base for regulators, retailers, and consumers.
02
Product Classification & Regulatory Pathway
Correct classification determines the entire regulatory approach for your product.
Appropriate Product Categorisation
We determine the correct regulatory category for your product within the target market, ensuring formulation, labelling, and claims are structured in line with applicable legislation.
Innovative Product Assessment
For novel or multifunctional formulations, we assess how the product will be interpreted under current regulatory frameworks, identifying potential compliance risks early and advising on adjustments where necessary.
Market Specific Framework Alignment
Regulatory requirements differ across regions. Therefore, we ensure your product aligns with local standards for composition, labelling, and claims, providing a clear and practical pathway for launch.
03
Labelling & Technical Compliance
Even scientifically robust products can fail without accurate and compliant labelling.
Label Review
We ensure all required elements are correctly displayed, including ingredient lists, allergen declarations, nutrition information, and reference intake values, in line with local legislation
Quantitative Ingredient Declarations (QUID) Assessment
Where applicable, we provide guidance on accurate reporting of active ingredient amounts, ensuring transparency and compliance with regulatory expectations.
Advisory & Warning Statements
Age restrictions, usage directions, and safety warnings are included where required, protecting both consumers and brand reputation while reducing liability.